chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received on 14 October 2011 from the patient. A female patient with no concurrent illnesses, and no known allergies had received a first left arm dose of FLUZONE HIGH-DOSE (lot number unknown) on an unknown date and after vaccination developed itchy hives over her trunk that lasted 1 week to 10 days. The symptoms resolved without medical treatment. It was noted the patient was taking concomitant medications that included ZOCOR, "ALTASE", ASA, LANTUS, and HUMALOG. Indications for medications were not reported. The reporter did not want to provide any further contact information for follow-up. No further information is expected. Documents held by sender: None.
11/11/99, noted to have URI, was immunized - pt remained playful, and  well hydrated.11/12  pt. was fussy in am, gave bottle and put on couch to nap.45 min later not breathing taken to ER. Resusc. unsuccessl, Dx full arrest. Suspect SIDS.
pt recvd vax & 3 hrs later exp swollen dry throat, h/a & swelling of the eyes, ears, & lips; 8 days later pt devel pneumonia;
sx started evening of 10/16/99;cranky, fever, rash;mom called for advice because rash looked like chickenpox;
Information has been received from a pharmacist concerning a male who in approximately 1997, about ten years ago was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck). In approximately May 2007, the patient's titer level was done, showing no antibodies and is scheduled for second dose of varicella virus vaccine live (Oka/Merck) soon. Unspecified medical attention was sought. No product quality complaint reported. No further information is available.
Post vax, the pt suffered from hypotonia, encephalopathy and autism. Pt developed a lump at injection site and irritability. Pt was given Tylenol.
I was soo tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (I was soo tired) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 025B21A) for COVID-19 vaccination.     The patient's past medical history included Miscarriage of pregnancy in February 2020.   On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Mar-2021, the patient experienced FATIGUE (I was soo tired). At the time of the report, FATIGUE (I was soo tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. No treatment information provided.   This case was linked to MOD-2021-114627 (Patient Link).
Fever, intense body chills, intense body/muscle aches, severe headache, mental fogginess all starting about 9 hours post vaccination continuing through now nearly 48 hours later
approx 24 hrs p/shot pt arrived @ ER w/swelling, redness, hives, pain, & fever; 12x12 cm area of erythema & induration surrounded shot site; tender & warm; Augumentin & DPH given;  poss cellulitis adm to hosp w/IV for 3 dasy;
PT SAYS THAT SHE BEGAN TO DEVELOP BLISTER LIKE SORES INSIDE HER MOUTH; THEY STARTED BEHIND HER TEETH AND HAVE SPREAD OUT TOWARD HER LIPS AND TOWARD HER THROAT. SHE SAYS THEY ARE PAINFUL AND DENIES ANY OTHER POTENTIAL CAUSES. DENIES TROUBLE BREATHING. WE ADVISED HER TO SEEK MEDICAL ATTENTION.
Patient received COVID 19 vaccine on 1/14/21 at approx 1428 without any complications. Patient was escorted to observation holding area for 15 minute observation post  injection. Patient held from 1430-1445 without any difficulties experienced by patient. Patient speaking frequently during observation period with another stakeholder. Patient left at 1445 after observation was complete. Patient returned at 1500 stating her throat felt strange and she was having difficulty swallowing water. Patient escorted to bay for monitoring. Vital signs BP 150/101, HR 70, O2 sat 99% on room air. Per physician order patient given 50 mg Benadryl PO and 10 mg Zyrtec PO. Vital signs at 1509 were BP 148/87, HR 72, RR not documented, pt breathing on room air.  Pt held and monitored. At 1610, pt stated "I feel something in my throat". Pt has no difficulty swallowing water.  1610 vital signs BP 138/92, HR 70, O2 Sat not recorded, breathing on room air.
This spontaneous report as received from a consumer refers her 64 year old husband. The patient's medical history included chemotherapy for cancerous cell in 2012 and had no known drug reactions/allergies. On 13-JAN-2010 the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not reported). Concomitant medication included cholesterol medication (brand, manufacturer and dose unspecified). On 29-AUG-2013, the patient developed pain in his shoulders and back, that progressed steadily until when he was hospitalized on 03-SEP-2013 until 08-SEP-2013. The patient was diagnosed with "shingles". Prednisone, NEURONTIN, (Manufacturer and dose unspecified) were used as treatment. Cat scan, blood work and X-ray were performed (results not provided). At the time of the report, the patient was still recovering (also reported as not recovered). Additional information has been requested.
Dizziness, Headache, Diarrhea, Arm numbness Narrative:
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 16-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-009507513-1905USA002751: 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-009507513-1905USA002770: US-009507513-1905USA002766: US-009507513-1905USA002767: US-009507513-1905USA002768: US-009507513-1905USA002769:
Patient given an adult dose of Pfizer when patient is a pediatric patient. Infectious disease doctors on site consulted, parents of patient notified of  error and given information and recommendations from infectious disease specialists.
The following individual had positive COVID results after completing their vaccine series. Date/Lot of 1st  dose: 12/22/2020 Pfizer EL0140 Date/Lot of 2nd dose: 1/12/2021 Pfizer EL1284  Date of COVID test: 4/6/2021 Date of exposure if known: 4/4/2021 Exposure (Workplace vs. community): Community Symptomatic: Yes
very fatigued; This is a spontaneous report received from a contactable reporter(s) (nurse). The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (DOSE 1, SINGLE), for COVID-19 immunisation. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "very fatigued". Additional information: The event occurred 24 hours after the second dose vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
p/vax pt noted substernal chest pain x 1-2 min;pt denies any other hx of such events;JEV concurrently administered w/1st 3 anthrax vax but anthrax alone was given #4 w/similar complaint;
Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium
Fever of 101, aches, chills, red arm, intense arm pain.  Also developed red patch on right arm with first vaccination.
On 03/05/2021 patient tested negative for SARS-CoV-2 and received the Johnson & Johnson (Janseen) vaccination prior her flight on 3/8/2021. She was fully vaccinated as of 3/19/2021. On 4/1/2021 and 4/2/2021 she met in a small office for an extended time with one other person, both wearing masks. Person stated he was not feeling well. On 4/7/2021 patient tested negative for SARS-CoV-2 prior her return flight. On 4/9/2021 she learned person she met with had tested positive for SARS-CoV-2. 4/10/2021 patient flew home. Later that same night, patient began to have what she described as allergy symptoms of throat drainage, runny nose and sneezing. She tested positive for SARS-CoV-2 on 4/13/2021. Her sample was sent to Department of Health and Environment for whole genome sequencing. Results have come back confirming her positive result and as of the time of this report no genome results are back.
Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Shakiness-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Weakness-Severe, Additional Details: About 1 minute after vaccine was administered, pt slumped down in the chair after stating that she doesn't feel good, brief LOC without head trauma, pt urinated on herself. After being alerted by provider we immediately activated EMS and had EPI and AED available however did not administer either, EMT evaluated and determined anxiety attack and offered ER admission - patient declined. Pt stayed in the clinic until her friend picked her up and they  all reported that they were going to the ER.
Numbness and tingling initial symptoms  led to ER visit.  Other symptoms developed over time. Brain fog, muscular pain  and tightness in diaphragm , ribs and hip. Extreme heart palpitations and extreme fatigue.  Dxed with POTS 8/21.   Within hours of receiving booster 12/21, numbness and line of pain along left side from head to shoulder. Within week, new chest pain, heart attack feeling, barely able to function, terrible brain fog and pressure in head.  Double and blurry vision with headache. High blood pressure . Struggles to get out of bed. Can?t work.
Little redness; Allergic reaction on her arm, swelling; Allergic reaction on her arm, swelling; This is a spontaneous report from a contactable consumer. This consumer reported for her wife that:  A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown, Expiry Date: unknown), via an unspecified route of administration on an unspecified date as 2ND DOSE, SINGLE for covid-19 immunisation.  The patient medical history was not reported.  The patient's concomitant medications were not reported.Historical vaccine include the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown, Expiry Date: unknown), via an unspecified route of administration on an unspecified date as 1ST DOSE, SINGLE for covid-19 immunisation.The patient experienced little redness, allergic reaction on her arm, swelling, allergic reaction on her arm, swelling on an unspecified date. It was reported that the patient took the shot of the Pfizer Covid-19 Vaccine, had an allergic reaction on her arm, swelling and asked how to get the swelling down, and for information about the Pfizer Covid-19 Vaccine. Reporter did not have the agency vaccine record card at the time of the call. Product: PFIZER-BIONTECH COVID-19 VACCINE. Question: The reporter stated his wife, got the second dose of the vaccine on Tuesday of this week and after the shot had a little reaction to it. Had a knot on her arm and a little redness so they put ice on it and the ice made it throb after 10 minutes. Asked how do they get the swelling down, do they put ice on it. agency- did not obtain more info or warm transfer because the reporter declined reporting this at this time because he needed to get in touch with a doctor before it starts raining there; stated will report later; e-transmitting details. Response: Referred to HCP for treatment recommendations. The outcome of events were unknown.  Follow-up (30Apr2021): New information include in response to this follow-up spontaneous report received from a contactable reporter. This reporter reported that: Clinical information updated.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Donated in September and received a letter from the people he donated blood to, stating that he has tested positive for "Warm auto antibody; This spontaneous case was reported by a consumer and describes the occurrence of AUTOANTIBODY POSITIVE (Donated in September and received a letter from the people he donated blood to, stating that he has tested positive for "Warm auto antibody) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Blood donation (Patient states he used to donate blood all the time).   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced AUTOANTIBODY POSITIVE (Donated in September and received a letter from the people he donated blood to, stating that he has tested positive for "Warm auto antibody). At the time of the report, AUTOANTIBODY POSITIVE (Donated in September and received a letter from the people he donated blood to, stating that he has tested positive for "Warm auto antibody) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Autoantibody test: positive (Positive) tested positive for "Warm auto antibody".         The patient stated that he used to donate blood all the time, and he donated in September, and then received a letter from the people he donated blood to, stating that he had tested positive for "Warm auto antibody". It caused minor harm, but it could cause anyone a problem if they had a transfusion, and they won't take patient's blood anymore. The patient stated that the only thing he could think that caused this was that he received the Moderna vaccine, and wanted to know if it is one of the side effects. Concomitant product use was not provided by the reporter. No treatment information was provided.
Rash all over body; This case was reported by a pharmacist via call center representative and described the occurrence of generalized rash in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st October 2018, the patient received Shingrix. On 1st October 2018, less than a day after receiving Shingrix, the patient experienced generalized rash. On an unknown date, the outcome of the generalized rash was unknown.   It was unknown if the reporter considered the generalized rash to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The reporter at Pharmacy reported that a female patient between the age of 55 to 60 years old, stopped by the pharmacy about a year ago, was not a customer of the pharmacy, and reported to him that she received the Shingrix and experienced a rash all over her body. The reporter consent to follow up. This is 2 of the 2 linked cases reported by the same reporter.
Menveo was administered by subcutaneous route; This non-serious case was reported by a nurse via call center representative and described the occurrence of intramuscular formulation administered by other route in a 19-year-old patient who received Men ACWY-CRM NVS (Menveo) (batch number AMA7928) for prophylaxis.   On an unknown date, the patient received Menveo (subcutaneous). On an unknown date, an unknown time after receiving Menveo, the patient experienced intramuscular formulation administered by other route (Verbatim: Menveo was administered by subcutaneous route).  The outcome of the intramuscular formulation administered by other route was unknown.   Additional Information: GSK Receipt Date: 06-OCT-2023 The nurse reported that Menveo was administered by subcutaneous route which led to intramuscular formulation administered by other route. The reporter consented to follow up via email. The vaccine administration facility is the same as primary reporter.
Rapid Heart Beat, Heart Flutters. Palpitations 1hr after receiving the shot. Symptoms were coming and going for up to one week. Seemed to have cleared up however, I have an EKG scheduled for the week of 10/2/2021.
red arm; chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red arm) and CHILLS (chills) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C71A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension (high blood pressure) and High cholesterol (high cholesterol). Concomitant products included ATORVASTATIN and AMLODIPINE for an unknown indication.    On 27-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (red arm) and CHILLS (chills). At the time of the report, VACCINATION SITE ERYTHEMA (red arm) outcome was unknown and CHILLS (chills) had resolved.            No treatment medication was provided.
Fever 102.5,  Rash over entire body.  Fever started 4/24/2008 and rash appeared 4/28/2008.  Very cranky and trying to itch skin.
Twenty-four hours post DTaP immunization, the pt developed red, and tender to touch area.
Pt recvd vax & exp local reaction; pts MD felt that it was due to yeast component; No further details provided;
(nerve) Pain in neck, shoulder and down right arm-started within hours of vaccine,  still an issue (nerve) Pain in bottom of feet started - 3 days after vaccine,  still intermittent issue Severe dizziness - started about 2 days after vaccine,  still intermittent issue
3-10-22 left arm swollen , face puffy, 3-11-22 cough, congestion , heart palpitations, 3-12-223 heart palpitations, short of breath, can?t walk due to hip pain, 3-13-22 short of breath, heart palpitations, left under arm and side of breast swollen , itching, 3-14-22 arm swollen as well as under arm and side of breast, heart palpitations
Pt has 4-5 inch diameter oval shaped red rash around injection site. Pt reports pain at the area "like a bruise". Pt says started night of vaccination.
Woke up on Oct 13th at 3am the right side of my face was paralyzed. I went to the ER thinking I was having a stroke, but the ER Dr diagnosed me with Bell's Palsey. I then followed up with my Primary Care physician and she diagnosed me with Bell's Palsey also. The ER dr prescribed me  a steriod, and an antiviral medication.
following day p/vax pt exp crying for 2hr or more, sl fever, dec appetite;TO ER;21OCT98 T101.2;diagnosis possible adverse reaction (crying/fever), poss esophagitis d/t thrust, ?acid reflux;
I was coughing with congestion. I had body aches and fatigue. I tested myself using a COVID-19 Home test on November 27th and that was positive. I went to Pharmacy, and they did an assessment for me and decided I was eligible for Paxlovid and prescribed.  My symptoms were mild the whole time. I had congestion, fatigue and body aches. I also had low oxygen saturation as low as 72. I also used cold medicine to reduce the congestion and improved to date I have not completed recovered. I requested a 2nd round of Paxlovid since my Oxygen levels were so low. The oxygen levels still did not improve. I returned to the doctor and was prescribed oxygen by a respiratory doctor. The doctor believes I have long COVID and possibly COVID Lung. I have overnight Test Oximetry Test on November 15, 2022, and it showed low average of 87% .
Nausea; had little hives here and there; vomiting; redness on wrists, hands; inflammation; This is a spontaneous report from a contactable consumer (patient). A 22-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 10Mar2021 at 15:00 hours (Batch/Lot Number: EN6204) as DOSE 1, SINGLE (at the age of 22-years-old) for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient's history of all previous immunization with the Pfizer vaccine considered as suspect was reported as none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was reported as none. The patient's medical History (including any illness at time of vaccination) was not reported. The patient's family History was not reported. On 11Mar2021, the patient experienced nausea, on an unspecified date in Mar2021 experienced vomiting, redness on wrists, hands, and inflammation. It was not reported whether the patient had admission to the hospital or received any treatment due to the events nausea, vomiting and redness on wrists, hands. On 11Mar2021, the patient started to feel nauseated and then had little hives here and there. The patient had not seen any new ones on the day of reporting and the inflammation seemed to have gone down; they were not as red on the day of reporting. The patient was more nauseated on the day of reporting. The patient queried for how long these side effects tend to last and Mentioned that this was the first vaccine reaction he has ever had and the first time he has had to call in to report anything without his parents doing it for him. The patient also queried whether he should still get his 2nd dose and for any recommendations on treatment for the symptoms. The patient had no relevant tests reported. The adverse events did not require a visit to physician or emergency room. The patient had no prior Vaccinations (within 4 weeks). The patient was recovering from the events inflammation and had little hives here and there; had not recovered from the event nausea and the clinical outcome for other events was unknown.  Follow-up attempts are needed.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
1 of 2 pts who was immunized from same DTP lot; dx poss cellulitis ( no cultures taken); afebrile; pt vaxed 3FEB93; devel 10mm area of redness & induration; 3cm away from site; also had macular papular rash & tenderness @ site;
Pt. had a syncopal episode as well as one twitching episode reported by patient's mother immediately after vaccine was administered.
Tdap vaccine given. Pt states left arm swollen, bright red, painful, and felt large knot. States fever x 4 days.
Start of COVID-19 symptoms on 10/15/2022. Moderna bivalent vaccine on 9/13/2022. 5th vaccine.