chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AEs; administered an expired dose of GARDASIL 9; This spontaneous report was received from a consumer referring to her son, a 11 year old male patient. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapies were not reported.  In June 2023, the patient was administered an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, route, lot # and expiration date were not reported) for prophylaxis. It was expired by 3 months (expired product administered). No additional adverse event (AE) was reported.
Fever again of 101.6 F; Diarrhea; Body aches; Annoying cough; Really bad and piercing pain in the left arm lymph nodes; enlargement of lymph nodes in the left arm; fever of 101.5F; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of LYMPH NODE PAIN (Really bad and piercing pain in the left arm lymph nodes), COUGH (Annoying cough), LYMPHADENOPATHY (enlargement of lymph nodes in the left arm), DIARRHOEA (Diarrhea) and PAIN (Body aches) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced MYALGIA (Sore arm). On 29-Apr-2021, the patient experienced PYREXIA (fever of 101.5F). On 30-Apr-2021, the patient experienced LYMPHADENOPATHY (enlargement of lymph nodes in the left arm). On 02-May-2021, the patient experienced LYMPH NODE PAIN (Really bad and piercing pain in the left arm lymph nodes). On 04-May-2021, the patient experienced COUGH (Annoying cough). On 05-May-2021, the patient experienced DIARRHOEA (Diarrhea) and PAIN (Body aches). On 06-May-2021, the patient experienced PYREXIA (Fever again of 101.6 F). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) at an unspecified dose and frequency. On 30-Apr-2021, PYREXIA (fever of 101.5F) had resolved. On 05-May-2021, DIARRHOEA (Diarrhea) and PAIN (Body aches) had resolved. On 07-May-2021, PYREXIA (Fever again of 101.6 F) had resolved. On 08-May-2021, LYMPH NODE PAIN (Really bad and piercing pain in the left arm lymph nodes) and LYMPHADENOPATHY (enlargement of lymph nodes in the left arm) had resolved. At the time of the report, COUGH (Annoying cough) and MYALGIA (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, 1 month after receiving Shingles vaccine and unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient got the Shingles vaccine and still got shingles. The patient got vaccinated and was told a month after the second shot the patient had a mild case of shingles. The patient stated that the vaccine did not solve the problem. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure, since the details regarding laboratory confirmation of shingles was not reported.
Aching in his neck; One time episode of seeing green dots on the television; Headache; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Aching in his neck), VISUAL IMPAIRMENT (One time episode of seeing green dots on the television) and HEADACHE (Headache) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: FLU VACCINE VII.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Sep-2021, the patient experienced NECK PAIN (Aching in his neck), VISUAL IMPAIRMENT (One time episode of seeing green dots on the television) and HEADACHE (Headache). At the time of the report, NECK PAIN (Aching in his neck), VISUAL IMPAIRMENT (One time episode of seeing green dots on the television) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Sep-2021, Blood pressure measurement: increased (High) Increased.         Concomitant information was not provided. Treatment information was not provided.   This case was linked to MOD-2021-354331, MOD-2021-354332 (Patient Link).
Patient developed unprovoked left femoral DVT on or about 2/10/21. First DVT. Treated with 6 months Eliquis. Unknown if related to vaccine series.
Received shot Wednesday at 7:00.  By 4:00 she was felling fatigued and developed muscle aches and leg cramps.  By Friday she was extremely sleepy  and her whole body hurt. She was having chills and "brain fog".  This lasted through Monday.  Today (Wed) she feels better but "just ok".  Still with drowsiness and fatigue.
Shortly after vaccination (roughly 1 -2 minutes) patient stood and felt dizzy/lightheaded and appeared very pale. She sat down in pharmacy waiting area (accompanied by mother and sister) and began to have a mild seizure. The seizure lasted approximately 30 seconds-1 minute. She waited for roughly 15 minutes while resting and being observed by myself and mother. Pt has known seizure disorder, but has never had a seizure as a result of the flu shot. I provided the patient with a sprite, after about 15 minutes, she felt much better and felt ok to walk out of the store and go home. I called patient roughly 2 hours later and 1 day later as well. Patient reported no further seizure activity. She stated feeling overall tired but was being monitored very closely all weekend by her mother. She reported she would notify her neurologist on Monday.
Headache, flushing face, tingling lips, balance off, general weakness,  pressure in throat, difficulty swallowing
Pt developed one hive only on Friday 12/18/09. More hives appeared on Sunday, 12/20/09. No other complications noted. No respiratory issues.
COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer (pfizer) concerned a 55 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 042a21a and expiry: UNKNOWN) dose was not reported, 1 total, administered on 31-MAR-2021 15:00 in left arm for prophylactic vaccination. Age at time of vaccination 54 years old. No concomitant medications were reported. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient received additional non-company suspect vaccine included: Moderna covid-19 vaccine (elasomeran) (dose number in series 2) (form of admin, route of admin was not reported and batch number: 032F21A expiry: UNKNOWN) dose was not reported, administered on 26-OCT-2021, 15:00 in left arm for prophylactic vaccination.  On an unspecified date in MAY-2022, the patient experienced covid-19 infection (dose number in series 2). On 17-MAY-2022, the patient took Paxlovid (ritonavir) for covid-19 treatment. On 27-MAY-2022, the patient had covid-19 virus test which resulted in positive (covid-19 infection) after feeling fine for a week (dose number in series 2).  The action taken with covid-19 vaccine ad26.cov2.s, and Moderna covid-19 vaccine (elasomeran) was not applicable. The patient was recovering from covid-19 infection. This report was non-serious.
Moderate Headache Shaking Chills Fever  Sweating Hot Flashes Injection Site Soreness Fatigue
10:00 AM: FACE FLUSHED, THROAT MODERATELY SWOLLEN & RED. 3:40 PM: DIZZINESS; TACHYCARDIA.
Hypermia, increase temp L deltoid area 8/22 and 8/23. Injection given 8/21. Also had Pneumovax 1991 without problems
Info has been received from a woman in a pediatric office concerning a 10 year old white male student (64 lbs) with no medical history, who on 1/9/98, was vaccinated with a 1st dose of varicella virus vaccine live (lot 624068/1101E). There was no illness at the time of vaccination. On 2/22/06, the pt developed a mild case of varicella. The pt was seen in the physician's office on 2/23/06. No treatment was reported. Subsequently, the pt recovered from varicella. No further info was available at the time of this report. Additional info is not expected.
headache; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). A male patient of an unspecified age received 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced headaches after the 2nd dose of the vaccine. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Patient reported an adverse reaction of redness, itching, pain and inflammation in an area surrounding the vaccination site. The affected area was approx. 4-5 inches in diameter. Patient reported event on 9/11/10. Patient was contacted 9/14/10 and reported that arm was much better, only slightly itchy occasionally.
After receiving my third dose of Pfizer COVID-19 vaccine, I ran fever and had aches and pains along with congestion for about a week. After recovering from the initial reaction to the vaccine, I continued and still continue to have sensitivity in my right arm at the injection site. The main issue though, is that around 2 or 3 weeks after my initial recovery from the vaccine, I developed an unceasing and chronic congestion with mucus that lasted for several months. I saw a doctor who prescribed Montelukast which helped. I still feel that I  get more easily congested than before, however.
pain in back & neck started 17OCT98-lymph nodes swollen;T99-101 then decreased;treat w/APAP every 4hr & rest, to return to MD 22OCT98 if not better;saw MD 20OCT98
12/01/2021 post vaccine, pain in my arm, 8 hours after the vaccine, mild fatigue. 01/05/2022 at 06:00 PM Shingles, treated it with Valacyclovir. 01/12/2022 I still have the Shingles; they are not gone. It will resolve. It usually takes me 2 or 3 weeks to get over my Shingles. I did call my doctor on 01/06/2021 at 01:00 PM and reported my Shingles. Note: The immune deficient people, total non-responder, less than 10% antibody response. How many doses of the vaccine do immune deficient people need? We are not immune compromised people. I would like a response. Thank you.
Patient was administered the Pfizer Pediatric (5-11) dose even thought patient age is 12 and should have gotten the Pfizer 12+ version
Pt reported that she had redness, warmth, and a large raised bump that formed a week after her injection. She had to take 10 days worth of antibiotic, her primary care physician told her she had an infection, and she continues to have a lump under the skin.
patient felt faint. was hypersensitive to touch. arm was swollen. redness and bruising occurred.
both were given and were already received a year ago; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 13-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 33ac7, expiry date 7th November 2022) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) (batch number amva568a, expiry date 31st May 2022) for prophylaxis.   Previously administered products included Boostrix (received 1st dose a year before the date of reporting) and Menveo (received 1st dose a year before the date of reporting).   On 30th September 2021, the patient received the 2nd dose of Boostrix and the 2nd dose of Menveo. On 30th September 2021, unknown after receiving Boostrix and Menveo, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were reported as follows: The Patient had already received Boostrix and Menveo a year before the date of reporting and on 30th September 2021 patient received Boostrix and Menveo again, which led to extra dose administered. The reporter consented to follow up.
Pt admitted for cellulitis of the right forearm post cat scratch. Pt stated that he tested positive on home test for COVID and was positive here. Pt had no fever, but just a cough.
rashes after HPV: 1. distinctive and discrete papular rash 15 cm area over deltoid 2. papular/??urticarial rash on face - itchy. No diffuse rash, no SOB or other systemic sx.
Given Tdap vaccine, red, swollen area size of fist at the site. No fever or other complaints.
Prevnar 13 and HIB given in right leg at 4 month visit that left raised red bumps with clear drainage. Mom states had fever after vaccines but did not report to physician until next checkup at 6 month visit on 12/16/13. No pain at injection sites. Dr. will treat for possible infection.
Second dose was administered at 14:40 on 2/5/2021 Tuesday 2/9/2021 I began breaking out in hives. They temporarily went away and return that evening covering 40% of my body
rapid heartbeat; fever of 100; body ache; chills; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (rapid heartbeat), PYREXIA (fever of 100), MYALGIA (body ache) and CHILLS (chills) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     The patient's past medical history included Hyperthyroidism and Thyroidectomy. Concomitant products included LEVOTHYROXINE for an unknown indication.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced HEART RATE INCREASED (rapid heartbeat), PYREXIA (fever of 100), MYALGIA (body ache) and CHILLS (chills). At the time of the report, HEART RATE INCREASED (rapid heartbeat), PYREXIA (fever of 100), MYALGIA (body ache) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 fever of 100.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided. she will seek immediate medical attention and contact her family HCP.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  However, the previous history of Hyperthyroidism, is a confounder.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  However, the previous history of Hyperthyroidism, is a confounder.
The pt was vaccinated with an expired vaccine, dated 07/08/2000.  The day of vaccination was 08/22/2000. On the same day post vaccination, the pt experienced pain at the injection site and had marked erythema starting approximately 2 cm below the injection site extending to below the elbow by the next day. On 08/24/00 there was induration but no tenderness. The pt was seen by a physician and treated with soaks, Duricef and Benadryl. On 08/28/00 the pt recovered. No further information is available.
2/6: approx. 7pm, left arm (injection site) began feeling sore; observed light pink skin coloration approx. same size as bandaid just above that covered injection site 2/7: while at work, mild flu-like symptoms developed throughout the day (fever, mild nausea, headache); upon arrival at home, experienced severe chills; spouse assisted in covering with blankets, placing floor heater nearby, using body heat to warm; took acetaminophen for fever; chills & fever off n on throughout the night 2/8: redness tripled in size; fever, aches persist; ER approx. 9:30am, diagnosed with cellulitis; administered IV antibiotics and prescribed Keflex, informed redness may grow slightly initially; advised follow-up with primary doc 2/9:  all other flu-like symptoms resolved; redness continuing to grow, covering outer half of upper arm 2/10:  primary follow-up @ 1:15pm; Dr surprised by reaction, marks outline of redness, advises ER if progression beyond border; prescribes doxycycline in addition to Keflex, first dose taken @ 2pm, second dose with Keflex @ 6pm; ER @ 8pm due to significant expansion beyond outline; vancomycin administered in ER, admitted for observation 2/11: vancomycin effective in reducing redness, continuing IV dosage at 12hr intervals; anticipating discharge 2/12, with further Keflex/doxy treatment in out-patient status
Swollen left arm, red, tender and hot.  Ice pack and 2 Advil daily.
Fatigue, headache, malaise, brain fog, body aches, mild nausea within 2 - 3 hours of shot
tightening in her throat area; hard to swallow; This is a spontaneous report received from a contactable consumer (patient). A 40-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 19Mar2021 (at 40 years old) (Batch/Lot Number: EN6205) as 1st dose, single for covid-19 immunisation. Medical history included allergy to shellfish from an unknown date. The patient had no concomitant medications. After first shot, patient felt tightening in her throat area for a short period where it was kind of hard to swallow and she took a Benadryl and it went away. The outcome of the events was recovered. No History of all previous immunization with the Pfizer vaccine considered as suspect. No Additional Administered Vaccines.  No AE(s) required a visit to Emergency Room or Physician Office. No Prior Vaccinations (within 4 weeks). No AEs following prior vaccinations.
Vaccine was given on 3/23/2021 @ 0900 and was uneventful. On 3/24/2021 at 2000, I experienced dizziness and nystagmus with nausea which lasted about 5 minutes and resolved after side lying. The nystagmus was a first time occurrence and has not reoccurred. At the same time ( on 3/24/2021), I experienced tinnitus for the first time. The tinnitus has continued to today.
Moderna vial pulled had a beyond use date of 5/18/2023. Vaccine administered on 5/21/2023. Moderna team determined vaccine maintained activity to provide protection against Covid-19.
hives all over face and body; This is a spontaneous report from a contactable other hcp. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), via an unspecified route of administration on an unspecified date as unknown, single for COVID-19 immunisation. hyaluronic acid (RESTYLANE), route of administration, start and stop date for an unspecified indication. Medical history and concomitant medications were not reported.The patient experienced at first didnt disclose the she took the covid-19 vaccine, SB patient came in 3 days post injection of Restylane Kysse in lips with hives all over face and body. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: Removed at risk classification, and event "at first didnt disclose the she took the Covid-19 vaccine".
Patient received covid booster and then that evening had chills and developed 3/10 left side chest pain. Currently undergoing evaluation
Arthus hypersensitivity.  Aches all over, sore left arm, fever 101 off and on for 3 days, L deltoid with edema, erythema, tender and induration.
High Fever 103.8 for two days, aches and pains flu like symptoms.  Then A week later I am now experiencing tingling, pain and numbness in my hands and feet. My hand go numb while I am sleeping. each day this continues to get more intense.  I am also experiencing insomnia
Swelling of right thigh area size of mosquito bite at injection site of Dtap per mother, Advised OTC children's Benadryl and cool compresses.
Flulaval, Havrix, Kinrix, Pediarix, Infanrix that was stored at 49.8F x 185.5 hours; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number 2YB4G, expiry date 30-JUN-2023) for prophylaxis.   Co-suspect products included HAV (Havrix) (batch number 9R5LC, expiry date 02-NOV-2024) for prophylaxis, DTPa-IPV (Kinrix) (batch number 5AY2J, expiry date 10-JUN-2024) for prophylaxis, DTPa-HBV-IPV (Pediarix) (batch number 4N2PM, expiry date 28-MAR-2025) and (batch number 25L32, expiry date 28-MAR-2025) for prophylaxis and DTPa (Infanrix) (batch number 7HM5J, expiry date 18-SEP-2024) and (batch number 7C9NJ, expiry date 10-NOV-2024) for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent 2022-2023 season, Havrix, Kinrix and Pediarix. On an unknown date, the patient received Infanrix. On 23-MAR-2023, an unknown time after receiving FluLaval Quadrivalent 2022-2023 season, Havrix, Kinrix, Pediarix and Infanrix, the patient experienced incorrect storage of drug (Verbatim: Flulaval, Havrix, Kinrix, Pediarix, Infanrix that was stored at 49.8F x 185.5 hours). The outcome of the incorrect storage of drug 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:14-JUN-2023 The health care professional (HCP) reported administration of Flulaval, Havrix, Kinrix, Pediarix, Infanrix that was stored at 49.8F x 185.5 hours (per audit, multiple excursions from March 23, 2023 - May 18, 2023).  It was unknown how many patients and which vaccines were administered during this period or up until the current date. The reporter did not consent to follow up. The vaccines were stored wrongly which led to Incorrect storage of drug.