chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had severe side pain; This is a spontaneous report from a contactable consumer (patient). A 38-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 16May2021 13:00 (Batch/Lot number was not reported) as single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced severe side pain on 17May2021 00:00 which resulted in hospitalization. Outcome of the event was not recovered. Therapeutic measures were taken as a result of severe side pain.   No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
Myalgia : headache, body aches "felt like bones were hurting", all around fatigue. Narrative:  Other Relevant History:
1740 received the vaccine; 1755 began occasional dry cough and raspy voice noted  168/80-100-20; started IV line and Solumedtrol 125 mg given IV; 1803 continued dry cough voice less raspy states cough less tight feeling; 1815  151/76-88-16 dry cough still;  1826 ambulate in the hallway then increased wheezing, dry cough and raspiness; 1843 given albuterol HHN ;  kept her and observed overnight and left in the am.
PATIENT'S MOTHER REPORTED SWELLING AROUND INJECTION SITE AND HOT TO THE TOUCH
Patient said she had pain and swelling at the injection site for 2 to 3 weeks.  Her arm was also red and swollen for 1 weeks.  Patient said she still has a bump in her arm at the injection site.  The bump is not visible, but she can feel it when she rubs the area.
FOCAL MOTOR SEIZURE 9/11/2021 ACUTE RENAL FAILURE, UNSPECIFIED  ACUTE RESPIRATORY FAILURE 9/11/2021 ACUTE RENAL FAILURE, UNSPECIFIED  ACUTE HYPOXEMIC RESPIRATORY FAILURE 5/3/2021 ACUTE RENAL FAILURE, UNSPECIFIED  ACUTE HYPERCAPNIC RESPIRATORY FAILURE 6/9/2021 ACUTE RENAL FAILURE, UNSPECIFIED  CHRONIC HYPOXEMIC RESPIRATORY FAILURE 8/2/2021 ACUTE RENAL FAILURE, UNSPECIFIED  CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 8/2/2021 ACUTE RENAL FAILURE, UNSPECIFIED  RESPIRATORY FAILURE, UNSPECIFIED ACUITY 10/8/2021 ACUTE RENAL FAILURE, UNSPECIFIED  FOCAL MOTOR SEIZURE 9/11/2021 HYPOXIA  ACUTE RESPIRATORY FAILURE 9/11/2021 HYPOXIA  ACUTE HYPOXEMIC RESPIRATORY FAILURE 5/3/2021 HYPOXIA  ACUTE HYPERCAPNIC RESPIRATORY FAILURE 6/9/2021 HYPOXIA  CHRONIC HYPOXEMIC RESPIRATORY FAILURE 8/2/2021 HYPOXIA  CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 8/2/2021 HYPOXIA  RESPIRATORY FAILURE, UNSPECIFIED ACUITY 10/8/2021 HYPOXIA  FOCAL MOTOR SEIZURE 9/11/2021 NONTRAUMATIC ACUTE KIDNEY INJURY  ACUTE RESPIRATORY FAILURE 9/11/2021 NONTRAUMATIC ACUTE KIDNEY INJURY  ACUTE HYPOXEMIC RESPIRATORY FAILURE 5/3/2021 NONTRAUMATIC ACUTE KIDNEY INJURY  ACUTE HYPERCAPNIC RESPIRATORY FAILURE 6/9/2021 NONTRAUMATIC ACUTE KIDNEY INJURY  CHRONIC HYPOXEMIC RESPIRATORY FAILURE 8/2/2021 NONTRAUMATIC ACUTE KIDNEY INJURY  CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 8/2/2021 NONTRAUMATIC ACUTE KIDNEY INJURY
5 days p/vax pt went to ER w/a fever & cellulitis which extended from the inj site to the wrist;tx w/Keflex & antihistamines & recovered;
Pt recvd 3 doses of Engerix-B & 6 wks following completion of the series titer test results indicated neg Hep B Core Antibody;
Information has been received from a physician concerning a female (age not reported) who on an unspecified date was vaccinated with Gardasil vaccine (lot# unknown) injection. Concomitant therapy on the same day included Menactra. Subsequently the patient developed a rash after receiving a dose of Gardasil vaccine. Medical attention was sought. Very little information was provided regarding this adverse experience. Additional information has been requested.
parent consent to vaccine but patient was under 18 years old. Technician gave the shot not knowing the age requirement.
Information has been received from a physician and a practice manager via company representative referring to a patient of unknown age and gender. On 01-DEC-2014 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23-10PK-0.5mlSD-PFS LLokwTip) (lot # K019386, expiration date 09-JUN-2016). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 48 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
chills; This case was reported by a consumer via call center representative and described the occurrence of chills in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   Concurrent medical conditions included type ii diabetes mellitus.   In October 2020, the patient received the 1st dose of Shingrix (intramuscular) and Influenza vaccine Quadrivalent 2020-2021 season (intramuscular). On an unknown date, less than a day after receiving Shingrix and Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced chills. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the chills was recovered/resolved.   It was unknown if the reporter considered the chills to be related to Shingrix and Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows: Four weeks before the date of reporting, the patient received 1st dose of Shingrix intramuscularly in the left arm and a flu shot intramuscularly in the right arm. The Patient reported on the same day after receiving the vaccines, he had chills that lasted about 20 hours and then resolved. The Patient reported he took Tylenol for the chills. The Patient did not have lot number or expiration date information for these vaccines. The Patient gave consent to follow up with HCP. For tolerance in 2nd dose of Shingrix, refer case US2020AMR225450; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR225450:same reporter.
Sore arm left upper radiating down to the elbow and to chest area. Aggravated by movement. Exam left deltoid firm and painful to touch. Warm to touch, no redness.
This initial spontaneous report was received from a 62 year old female patient referring to herself. Medical history and concomitant medications were not provided. She is allergic to all narcotics. On an unspecified date, the patient received ZOSTAVAX (dose, indication and lot # not provided). On 29-JUN-2017, the patient developed shingles on an unspecified area. She saw her physician and he gave her a "shot" of acyclovir. The outcome of the event was unknown. Additional information is not expected as the patient did not grant consent to follow up.
Patient admitted to acute care hospital approximately 7 weeks after receiving Janssen vaccine with thrombocytopenia.  Platelet count 4000 at PCP and patient advised to present to the ED.  On admission 5/5/21, repeat platelet count 8000.  Emergent CT completed which ruled out cerebral venous sinus thrombosis.  PT, INR, fibrinogen and d-dimer were normal.  Hematology felt that it was most consistent with immune thrombocytopenia and unknown if any relation to her COVID vaccination.
1st dose in 2021, 2nd dose not given; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in March 2021 in left arm).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 1st dose in 2021, 2nd dose not given). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 30-MAR-2023 The reporter was the patient. The patient did not want to give any demographics. She stated that she had not yet gotten the second vaccine of Shingrix. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
26JUL h/a, t104, n/v, t102.8, tonsillitis; rx ATB; throat red, lt arm red around inject site 2" sm nodule; Dx tonsillitis & intestinal virus;
1st dose on 18Sep2019, did not receive 2nd dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 18th September 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.      Additional Information: GSK receipt date: 09-September-2022 Reporters comment:  The reporter reported that the patient received 1st dose shingrix but did not received the second dose but planned to will received the second dose The reporter consent to follow-up. Additional Supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
about half the volume was leaked, not administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a 4-year-old male patient who received HAV (Havrix) (batch number D7HA9, expiry date 27-OCT-2024) for prophylaxis.   On 03-APR-2023, the patient received Havrix. On 03-APR-2023, an unknown time after receiving Havrix, the patient experienced accidental underdose (Verbatim: about half the volume was leaked, not administered). The outcome of the accidental underdose was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date:03-APR-2023. Reporter stated that patient moved while receiving Havrix vaccine and about half the volume was leaked and not administered to the patient which led to accidental underdose. The reporter consent to follow up.
Case number PHEH2012US022183 is an initial spontaneous report received from a nurse on 06 Nov 2012. This report refers to a 27-years-old male patient. He was vaccinated with MENVEO (batch number: not reported) intramuscularly on 05 Nov 2012. It was reported that the patient received a partial dose which was less than 0.5 ml of the vaccine. No adverse event was reported following the maladministration.
COVID positive on rapid test, muscle aches, fever, nausea, headache, diarrhea.  Treatment, Paxlovid, course of illness 6+ days
Irritability, lethargy, vomiting for 36-48 hr symptoms started 30-60 after immunizations.
I don't feel good; rash all over the body, spots, in a couple of spots; shaking; throwing up; sick; This is a spontaneous report from a non-contactable consumer reporting for herself. A female patient of an unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in Apr2021 at single dose for COVID-19 immunisation. Relevant medical history included that she had Stevens-Johnson syndrome and was in the hospital for a month because she had a reaction to vancomycin and almost had a liver transplant. Concomitant medications were not reported. The patient reported that on an unspecified date she did not feel good, woke up with breaking a rash all over the body, spots, in a couple of spots, shaking, throwing up, sick. She have been through urgent care and nobody had any idea. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
developed a rash on the same arm that she received the vaccine/ located in the crease of the elbow and about 5 inches in diameter/ red and hot; This is a spontaneous report from a contactable consumer (patient). A 24-year-old female patient (not pregnant) received the first dose of (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247) at left arm on 25Jan2021 at 09:00 (24-year-old at time of vaccination) at single dose for COVID-19 immunization. The patient's medical history was not reported. There were no known allergies. The patient had no COVID prior to vaccination. Concomitant medications were not reported. The patient did not received other medications in two weeks. The patient did not received any other vaccine in four weeks. On 01Feb2021 at 08:00, the patient developed a rash on the same arm that she received the first dose of the vaccine. Developed rash around a week after the first shot. Rash is located in the crease of the elbow and about 5 inches in diameter. Rash is red and hot. Put cortisone on the rash and it got better. The event resulted in doctor or other healthcare professional office/clinic visit. The patient did not test COVID post vaccination. Therapeutic measures were taken as a result of the event and included cortisone. The outcome of the event was recovering.
Patient was inadvertently administered Pfizer bivalent COVID-19 vaccine that was beyond the best use date. Vial was left at room temperature for ~9hrs past the 12hr best use timeframe.
Severe pain at shot site and in shoulder.  hurts to move arm.  Shot was given very high in shoulder suspected SIRVA.  Started very soon after vaccine.
Additional booster: administered expired Bivalent booster Moderna COVID-19 vaccine after the 30 day beyond use date. Vial was initially stored in the refrigerator on October 24, 2022 and administered to patient December 1, 2022. No symptoms.
Infant died in his sleep. Infant found unresponsive. Autopsy states cause of death as undetermined. Interstitial pneumonitis was a contributing factor in the death. Also noted were subdural neomembranes.
Tonic/clonic sz, rt side; No fever prior to episode; Admitted to hospital; Stable as of 3DEC89; 2nd DTP, no prior rxn; Had 1st inject from same vial as this inject;
Sore arm; increased breakthrough bleeding; Heavier and bright red (fast flowing) than otherbreak through bleeding; Mild cramping; This is a spontaneous report from a non-contactable consumer, the patient. A 20-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the arm left on 03Apr2021 at 15:00 (at the age of 20-year-old), as a single dose for COVID-19 immunisation. Medical history included panic disorder, anxiety, severe polycystic ovarian syndrome (PCOS), lactose intolerant and allergy to molds (outdoor tree mold allergy). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included cetirizine hydrochloride (ZYRTEC) for an unknown indication from an unknown date and unknown if ongoing; ethinylestradiol/ ferrous fumarate/norethisterone acetate (LO LOESTRIN FE) taken for birth control from an unknown date and was ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Apr2021 at 13:00, the patient experienced a sore arm. On the same day, the patient had breakthrough bleeding which started unexpectedly less than 24 hours after the vaccine even after being on birth control (LoLoestrin FE a low dose oral contraceptive). The breakthrough bleeding was not that severe and the patient had used only 1 pad per day. On 04Apr2021, the patient had mild cramping and noted that her breakthrough bleeding was heavier and bright red (fast-flowing) than any other breakthrough bleeding which the patient had experienced and had always been very minimal and dark brown. It was reported that breakthrough bleeding lasted for about 7 days (until 10Apr2021) with no other side effects. The events did not result in doctor or other healthcare professional office/clinic visits, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sore arm and mild cramping were recovered on an unknown date in Apr2021, while that of the event increased breakthrough bleeding and heavier and bright red (fast-flowing) were recovered on 10Apr2021.  No follow-up attempts are possible. No further information is expected.
10nov89 pt vax hepta B. pt ex n/v flushing and warm feeling for 24 hrs.  13nov89 pt noted feeling weak.
Two Pfizer vaccines recorded in  record/ web report, although does not record.   Case was admitted to on 12/11/2021 and tested positive for COVID, died on 12/12/2021
Fatigue; Swelling and burning in her feet; Burning in her feet; Tingling in my fingers; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling and burning in her feet), BURNING SENSATION (Burning in her feet), PARAESTHESIA (Tingling in my fingers) and FATIGUE (Fatigue) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 027C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Jun-2021, the patient experienced PERIPHERAL SWELLING (Swelling and burning in her feet), BURNING SENSATION (Burning in her feet) and PARAESTHESIA (Tingling in my fingers). On an unknown date, the patient experienced FATIGUE (Fatigue). At the time of the report, PERIPHERAL SWELLING (Swelling and burning in her feet), BURNING SENSATION (Burning in her feet), PARAESTHESIA (Tingling in my fingers) and FATIGUE (Fatigue) 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.   Concomitant medications were not reported . Treatment The patient went to the health club and began to exercise on 07Jun2021, and the tingling went away
First dizzy, increased blood pressure-racing pulse, nauseous, bronchial spasms, difficulty breathing and speaking- Taken to ER given BENADRYL and anxiety medicine by IV-Prednisone 5 days
Aches, Headache, slight fever on 10/15/2009.  By 10/16/2009, all symptoms worse, fever 103.2, visited walk in clinic - diagnosis - more than likely - H1N1 as a result of the live virus vaccine.  Said no treatment available except medicine to control fever, rest and lots of fluids.
I have some sort of skin reaction/fungus/rash/breakout where round-ish red blotches (about the size of a dime or smaller began appearing  on the backs of my hands. Rash/blotches moved up my arms and spread to my lower legs until I contacted family doctor. Not sure at all if this is related to the COVID vaccination (and I doubt it is) but I wanted to at least report it. Treated/Treating with anti-fungal cream (Lamisil)  1 x daily at doctor's suggestion and it is effective on my lower legs, but keeps returning to my hands and forearm areas. Areas are very itchy and when it gets unbearable I treat specific areas with Cortizone cream (doctor's suggestion). Will be visiting doctor again if no improvement within 3 days on hands. The reddish affected areas start to dry the skin out and skin flakes as treatment gets underway.
2/4/2020  vaccination I got this done for work. Cognitive issues; fog. Ate dinner. took bath, body hurting. Woke up crying in sleep, whole body hurt. Everything hurt, cold sweats. Injection site, nodule, swollen. Winded and fatigued. Didn't go to dr this time.   First vaccine; Cognitive issues, blurry vision. Went home.
pt recv vax 16MAY96 & that day pt exp mild case of v/n;pt  was not seen by MD for exp;pt recovered following day;27JUN96 pt was given 2nd dose & no problems were noted;
I am having hives on arms and legs seems to be getting progressively worse as time goes on I di not initially have them at the time of the vaccine no swelling or other symptoms but each week they seem to worsen itching and welts forming
Aching in L shoulderx 3 weeks. Swelling which was red and tender in axilla on L where seasonal influenza injection was given in deltoid x 1 week.
15 YEAR OLD RECEIVED 0.1-0.2ML OF JANSSEN VACCINE. WHEN THE NURSE REALIZED IT WAS THE WRONG VACCINE, SHE PULLED IT OUT OF HIS ARM. I CALLED JANSSEN TO SEE IF THEY HAD ANY DATA ON THIS SCENARIO THAT REFERENCE NUMBER WAS 02403017 AND THE 2ND REFERENCE NUMBER WAS 02403165
Patient /1st dose / 2 years ago but never completed the series; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (first dose of shingrix vaccine received 2 years ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The age vaccination was not applicable for this report. Lot and expiration date were unknown. The reporter stated that the patient never completed the series with 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter stated that not all information was available.
Came to Dorney on 4/28/21 for her second Moderna COVID vaccine.  She has a history of food allergies and IV contrast dye.  She took 50 mg of Benadryl and Pepcid 20 mg prior to arrival for the vaccine.  She did not have any SOB, no chest pain and no swelling or difficulty swallowing.  She was seen by PA.  Her lunges were clear.  Her pulse ox was 97%.  Her B/P was 134/93.  Her heart rate was 94,  She was given another dose of Pepcid 20 mg.  No other issues noted.
Systemic allergic reaction causing all over body itching. When scratched, welts appear and then resolve on their own. Benadryl and Claritin have worked to alleviate the itching. It is still continuing a few weeks after the injection, but is not as intense and is less bothersome by the day.
pt recv vax 4OCT95 & JUL97 pt devel chickenpox;pt recovered;
This spontaneous report was received from a medical assistant and refers to multiple unspecified patients of unknown demographics. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients received doses of improperly stored PNEUMOVAX 23 (lot # L018503, expiration date: 16-MAR-2017; lot # L012521, expiration date: 01-FEB-2017; dose and route were not provided). The vaccine underwent temperature excursion of 1 degree Celsius for 158 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.