chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a distributor who was informed by a physician concerning a 57 year old female who on 24-SEP-2010 was vaccinated with a dose of PNEUMOVAX 23 (lot # 663888/0627Y, expiration in November 2010). On 24-SEP-2010 the patient developed numbness in the arm she received the PNEUMOVAX 23. It was reported that the patient received care from an emergency room and followed up with her doctor after that. At the time of reporting, the outcome of the event was unknown. Follow-up information has been received from a healthcare professional who reported that the 57 year old female on 24-SEP-2010 was vaccinated with a dose of PNEUMOVAX 23 (lot # 663888/0627Y, expiration in November 2010). She went to the emergency room complaining of her whole arm was in pain and she could not left her arm. The administered a steroid injection and gave her naproxen. "Today" she went to a walk in clinic complaining of soreness and muscle ache all over. They did not give her anything so she came back to their office where they administered a steroid dose pack. This is one of the cases received from same source (a distributor). Additional information has been requested.
This is a spontaneous report from a non-clinical study program from a contactable nurse who reported for a patient. A female patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration on 14Aug2015 at single dose. The patient medical history and concomitant medications were not reported. The patient was admitted to emergency room between 14Aug2015 and 24Aug2015 with side effects: sore arm, no appetite, chilling, high temperatures and her chest felt raw. An echography was performed which show large cardiac effusion pericarditis and the patient was scheduled to visit her cardiologist on 28Aug2015 and to see if she had gotten better, if not they have to drain the fluid. The cardiologist mentioned it as Post vaccination inflammatory pericarditis. The patient underwent lab tests and procedures which included blood test on an unknown date: results unspecified. Outcome of the events were not reported.
Pt reported fever of approximately 100.00 F, chills, and general malaise roughly one hour after vaccination.
Fatigue; headache; muscle pain; chills; This is a spontaneous report from a non-contactable consumer, the patient. A 31-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 01May2021 at 11:00 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. The medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included ascorbic acid (VITAMIN C), zinc (MANUFACTURER UNKNOWN) and virgin coconut oil (COCONUT OIL), all from unknown dates and for  unknown indications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 01May2021, the patient experienced fatigue, headache, muscle pain and chills. Therapeutic measures were not taken as a result of the reported events. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fatigue, headache, muscle pain and chills was not resolved at the time of this report.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Facial and widespread numbness; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of HYPOAESTHESIA (Facial and widespread numbness) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) and CYANOCOBALAMIN, PYRIDOXINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE (VITAMIN B 1-6-12) for an unknown indication.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced HYPOAESTHESIA (Facial and widespread numbness). At the time of the report, HYPOAESTHESIA (Facial and widespread numbness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were provided.   Reporter did not allow further contact
PATIENT STATED SHE HAS DEVELOPED A RASH WITH HIVES ON HER HANDS
Information has been received from a registered nurse concerning an over 60 year old female who in June 2002 was vaccinated with a dose of PNEUMOVAX five years ago.  Subsequently the patient developed a severe reaction with a rash.  Additional information has been requested.
After 5-6 days I broke out into sever shingles in the buttocks area, several other symptons as well like difficulty urinating, chills, migraine
Information has been received from a healthcare worker concerning a 4 year old female with no allergies or medical history who on 25-OCT-2002 was vaccinated with a dose of Varivax. There was no concomitant medication. On 04-JUL-2006, the patient developed red, raised bumps diagnosed as chickenpox. Unspecified medical attention was sought and no treatment was required. No diagnostic laboratory tests were performed. At the time of the report, the patient had not recovered. A product quality complaint was not involved. Additional information has been requested.
No additional AE information; temperature excursion; Information has been received from an administrator referring to a 17 years old patient of unknown gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.  On 15-MAR-2021, the patient was administered improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # 1687290, expiration date: 06-SEP-2022, strength, dose, frequency and route unknown) for prophylaxis (incorrect product storage). No adverse effects were reported.  The stored temperature was 1.48 degree Celsius. The time frame was 0.35 hours on 01-MAR-2021. There was no previous temperature excursion. The temperature excursion was detected by a data logger.  This is one of several cases received from the same reporter. ; Sender's Comments:  US-009507513-2105USA004751:
3 hrs after vaccination began the body aches accompanied by sore arm and nausea. 10hrs later developed a fever and chills. Had to take tylenol to function and went to bed. The next morning experienced just a headache and a sore arm which resolved within 48hrs.
feeling a little woozy/dizzy; My head was sideways and every time I would raise my head the room was spinning; there is not enough spit in my mouth. It's very dry; I walked very slowly; slight headache; My blood pressure now is 137/93. It was high this morning; felt lousy like I had the flu; felt like I was fainting; This is a spontaneous report from a contactable consumer.  A 68-years-old female patient started to receive received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at SINGLE DOSE for COVID-19 immunisation. Medical history included transient ischaemic attack (I had a TIA prior). The patient's concomitant medications were not reported. The patient experienced "feeling a little woozy/dizzy" on an unspecified date with outcome of unknown, "my head was sideways and every time I would raise my head the room was spinning" on an unspecified date with outcome of unknown, "there is not enough spit in my mouth, it is very dry" on an unspecified date with outcome of unknown, I" walked very slowly" on an unspecified date with outcome of unknown, "slight headache" on an unspecified date with outcome of unknown, "my blood pressure now is 137/93. it was high this morning" on an unspecified date with outcome of unknown, "feelt lousy like I had the flu" on an unspecified date with outcome of unknown, "felt like I was fainting" on an unspecified date with outcome of unknown. Reaction description by the reporter:" I had no pain, slight headache. My blood pressure now is 137/93. It was high this morning when I talked with the triage nurse. I had the shot/vaccine (first dose) on Friday. I feel better today than yesterday. Friday I felt fine. I got symptoms yesterday. When I woke up yesterday. I was feeling a little woozy, I always stretch slowly in bed. I slowly raised myself on the bed but before I got up my torso fell backwards. I felt like I was fainting. The room was spinning. All day yesterday I did not drive. I walked very slowly. I was holding onto the wall. I felt lousy like I had the flu. I would lay down for 20 minutes, watching tv. My head was sideways and every time I would raise my head the room was spinning. Also there is not enough spit in my mouth. It is very dry. I had a slight headache. So I did not bother but no headache today. I supposed to get my 2nd dose on 02Feb2021. The action taken was not applicable. Information on the Lot/Batch number has been requested.
COVID Breakthrough. Patient presented to the hospital on 12/31/21 with "several days" of shortness of breath that has been worsening. She also has cough, myalgias, and headache. The patient is positive Covid-19.
autonomic dysreflexia; vomiting; chills; sweating; muscle pain/I still have muscle pain in my shoulders and neck; my head and heart were pounding; my head and heart were pounding; felt bad; This is a spontaneous report from a contactable nurse (patient). A 31-year-old female patient received second dose of BNT162B2 (PFIZER COVID 19 VACCINE), via an unspecified route of administration, administered in Arm Left on 18Feb2021 (Lot Number: EN6201) at age of 31 years as single dose for covid-19 immunisation. Medical history included spinal cord injury due to MVA in 2012, neurogenic (incontinent) bladder and bowel, bladder augmentation and mitrofanoff, chronic neuropathic pain, dependent of wheelchair. Patient had no known allergies. Concomitant medications included lavender oil (lavender, helichrysum, jasmine). Historical vaccine included first dose of BNT162B2 administered in Arm Left on 28Jan2021 01:45 PM (Lot Number: EL8982) at age of 31 years as single dose for covid-19 immunisation and no reaction on previous exposure to drug. With first menstrual period after receiving vaccine patient had vomiting, chills, sweating, muscle pain, and her head and heart were pounding. It felt bad enough to go to emergency room but she waited it out at home and it lasted a few hours. Patient had a spinal cord injury so the symptoms were similar to what she got with autonomic dysreflexia, but this was the worst case of it she had ever had. She hadn't vomited in 10 years (or before her spinal cord injury). Patient still had muscle pain in her shoulders and neck. Adverse event start date was on 25Apr2021 12:00. No treatment received. No covid prior vaccination. No covid tested post vaccination. Outcome of events was recovered.; Sender's Comments: Based on the current available information, the event Autonomic dysreflexia is most likely related to an intercurrent or underlying condition which is not related to the suspected drug.  Medical history of spinal cord injury due to MVA in 2012 may provide a plausible explanation for the event. The case will be reassessed if additional information becomes available.  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 Committees and Investigators, as appropriate.
This person received a third dose. Patient was motivated to receive gift card for vaccine and indicated this was the first dose. Upon a record reconciliation we found this to be the 3rd dose. No adverse health outcome.
Pt. mother said she noticed the arm a little red and swollen, hot in the area in the afternoon 8/7/12. We told mom to apply warm compress and if not better to give us a call. I will call pt. to f/u on him.
So that Sunday i woke up, things started to smell different. I did a e-visit, the doctor that I visited said I need to get a COVID test. So I went back & took the test. The doctor gave me a inhaler albuterol. so I went to my primary care today for a 2nd opinion. so I started losing my taste & smell, I started to get really scared. I lost my taste & smell for 11 days. My congestion cleared up after I received antibiotic's from the doctor.
Exposure during breast feeding; This spontaneous case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING BREAST FEEDING (Exposure during breast feeding) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     Concomitant products included VITAMIN D3, BIFIDOBACTERIUM INFANTIS, LACTOBACILLUS ACIDOPHILUS (PROBIOTIC [BIFIDOBACTERIUM INFANTIS;LACTOBACILLUS ACIDOPHILUS]) and MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Exposure during breast feeding). On 10-Mar-2021, MATERNAL EXPOSURE DURING BREAST FEEDING (Exposure during breast feeding) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.  Patient had no side effects were reported after the first dose.; Sender's Comments: This is a case of product exposure during breastfeeding with no associated AEs. Patient will continue to be contacted for further monitoring of AEs.
Redness, irritation, swelling around injection site. Patient also felt generally not well, some fever. Onset was not immediate but within 12 hours of receiving immunization. Patient was treated with triamcinolone cream and lidocaine gel for the itching/irritation/pain.
general fever after the second dose; little headache after the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (general fever after the second dose) and HEADACHE (little headache after the second dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (general fever after the second dose) and HEADACHE (little headache after the second dose). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, PYREXIA (general fever after the second dose) and HEADACHE (little headache after the second dose) had resolved.            Concomitant medication was not provided.  as treatment the patient took tylenol, and drinking water for the fever.  it was stated that the patient had the general fever and a little headache, but it went away after a day.     This case was linked to MOD-2021-300002 (Patient Link).
Five minutes after injection, experienced a sense of doom, shortness of breath, and blood pressure/heart rate significantly above baseline. I was monitored with vital signs for the next 45 minutes and the symptoms resolved. For the next several days, experienced injection site pain and fatigue.
3 days later I got shingles in my one nasal passage; Received second dose / with adverse reactions ( swelling / at site); Received second dose / with adverse reactions ( / redness at site); This case was reported by a consumer and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th June 2021, the patient received the 2nd dose of Shingrix. In June 2021, 3 days after receiving Shingrix, the patient experienced shingles, injection site swelling and injection site erythema. On an unknown date, the outcome of the shingles, injection site swelling and injection site erythema were not recovered/not resolved.   It was unknown if the reporter considered the shingles, injection site swelling and injection site erythema to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient herself/himself. The age at vaccination was not reported. After receiving 2nd dose of shingrix vaccine, the patient experienced  injection site swelling ,injection site erythema and shingles. Shingles was happened 3 days after getting the 2nd dose of Shingrix  vaccine. No further information was reported. Follow up was not possible as no contact details were provided.
PT LOST CONSCIOUSNESS WITHIN 15 MIN OF ADMIN. PT WAS MILDLY DIAPHORETIC. VITALS WERE NORMAL. BP 124/75 HR 74  NO CPR NO EPI NEEDED.   ICE PACKS APPLIED TO COOL PT  .      911 CALLED   PT WAS TRANSPORTED TO HCF by EMS. PER PT REQUEST.
Patient appeared to be unable to see during the night two days after receiving the vaccine. She seemed to grope for her mother without seeing her. In the morning, she asked, "What happened to eyes?" She also had fever and cold symptoms for two days.
also experienced hives the next day in the same areas after the second dose; 1st dose on 1/27/2021 / second dose which she received on 3/10/2021; This case was reported by a consumer via call center representative and described the occurrence of generalized urticaria in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 10th March 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 10th March 2021, unknown after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short. On 11th March 2021, the patient experienced generalized urticaria. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the generalized urticaria was not recovered/not resolved and the outcome of the drug dose administration interval too short was unknown.   It was unknown if the reporter considered the generalized urticaria to be related to Shingrix.  Additional details were provided as follows: This case was reported by a patient herself.  The patient experienced hives behind ears, thoracic region, belly region and a couple behind knees and on arms, on the next day after vaccination. The reporter consented to follow up. This is 1 of the 3 cases, reported by same reporter. For tolerance of 1st dose refer case US2021061356.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021061360:same reporter US-GLAXOSMITHKLINE-US2021061356:same patient
Vial was opened but refrigerated for longer than 12 hours; mistakenly thought that the storage for Moderna had increased to 24 hours in the refrigerator instead of unpunctured, unrefrigerated for 24 hours. 2 doses were administered from that particular vial (also reporting another patient); no adverse effects were reported; manufacturer was consulted/notified; patient was also notified; incident report also reported at the pharmacy level; storage guidelines have been updated, posted and communicated with all pharmacy employees.
Client doctor sent a note to our facility reporting  patient was seen in his office 2/23/21 and client had a severe, diffuse, rash reaction and recommended he does not receive 2nd dose
Chest pain; shortness of breath; elevated heart rate; fever; joint pain; muscle pain; This is a spontaneous report from a contactable consumer (patient). A 37-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported, Expiry date: not reported), via an unspecified route of administration in left arm on 13Jul2021 12:00 (at age of 37-years-old) as dose 1, single for covid-19 immunisation. Medical history included allergy to tomatoes, bell peppers, mushrooms, almonds, gluten sensitivity, covid-19. There were no concomitant medications. The patient had not received any other vaccine within 4 weeks. Prior to vaccination, the patient was diagnosed with COVID-19 and post the vaccination, the patient was not tested for COVID-19. On 14Jul2021 11:00, the patient experienced chest pain, shortness of breath, elevated heart rate, fever, joint pain and muscle pain. The patient underwent lab tests and procedures which included heart rate: elevated on an unspecified date. The outcome of the events was unknown.  Information about lot/batch number has been requested.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Presented to Medical Treatment Facility on 20June06 with c/o HA, Chills, Nausea, sore throat x 24 hours. Temp 99.1. L shoulder vaccination site within normal limits. Slightly swollen lymph nodes neck. Diagnosed as viremia. Strept culture negative. Tylenol and quarters x 24 hours.
Aches; sore arm; Extremity tingling feeling; Fatigue; This is a spontaneous report from a non-contactable consumer. A 32-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unknown date (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unknown date, the patient experienced aches, sore arm, extremity tingling feeling and fatigue. The clinical outcomes of the events aches, sore arm, extremity tingling feeling and fatigue were recovered on an unknown date.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Day after (3/31) I felt shaky and uncoordinated - enough that I did not want to go on a step ladder.  Next day  (4/1) I was dusting lower shelves at home and when I stood up felt a snap in my lower back. Sharp pain which seemed to expand to my spine and lower torso -- basically forced me to bed for several days.  Pain has persisted since then, and while it seems to be improving it has continued to inhibit daily activities, especially bending.  This has been accompanied by bouts of tremors, shaking etc. (particularly in my arms and hands) as well as a sense of tremors even when there aren't any.  There is also a persistent sense of not knowing exactly where I am in space.  I drop things more frequently.  While I have had some back problems in the past, these upper body manifestations are entirely new.
2 weeks after the first vaccine, I felt exhausted, my joints became very painful, especially my shoulders and hips. The pain made it difficult to complete simple tasks, such as putting on clothes, sitting, sleeping, or even walking. I had blood tests recommended by my physician on  February 24th.