chrisvoncsefalvay/vaers-outcomes huggingface dataset:
About 11 am I was masked in church and developed a tickle in my throat.  I cleared my throat to no relief.  I took 2 cough drops. About 11:30 I got a bottle of water.  No relief after drinking 8 ounces.  I left the service, went outside, removed my mask and was coughing forcibly for about 15 minutes or so.  Expectorated clear phlegm 6 - 8 times.  Gradually I settled to normal.  Just some residual soreness in throat.  This was an unusual occurrence for me.   I was covid positive in early Dec, but had a very mild case. Back in the 70's I would have reaction to allergy shots.  I waited in the office 15 minutes, but 45 minutes later when I arrived home I had huge hives and severe itching.
This is a spontaneous report from a contactable pharmacist (reporting for a family member) .  A male patient of an unspecified age received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE),  via an unspecified route of administration on 01Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient experienced showed symptoms of Covid and tested positive   (medically significant) on Apr2021. It was reported  the patient received the first dose of the Pfizer COVID on 01Apr2021 and about 10 days out they showed symptoms of COVID and tested positive.  The patient underwent lab tests and procedures which included sars-cov-2 test: positive  on Apr2021  Caller is asking how long he has to wait to get the 2nd dose. Caller refused to provide details of the patient. The clinical outcome of the events was unknown.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on available information, a possible contributory role of the subject product,  BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 and suspected LOE.   There is limited information provided in this report.  This case will be reassessed once additional information is 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Started on 9/9/21 at around 6pm shortness of breath began. Lasted around 2 day until 9/11/21. Dizziness and nausea began 9/15/21 and continue until present time 9/17/21. Patient is experiencing hard to focus vision. Patient is also experiencing severe swelling, tenderness, and itchiness in injection site that began 9/16/21 and ongoing.
Over 24 hours after being given the vaccine, the patient reported to the ER with hives and lip swelling. The patient was given one dose of solumedrol in the ER then discharged with no problems. The patient has a history of allergies to foods and medications.
TOOK SHINGLES ANYWAYS; hurt me so bad; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles and pain. On an unknown date, the outcome of the shingles and pain were unknown.   It was unknown if the reporter considered the shingles and pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 28-Apr-2022 Reporter's comments: This case was reported by patient via interactive digital media. The patient reported that shingles hurt so bad. The patient got the 1st shingles shot and took shingles anyways. The patient heard that the 2nd shot would better and need to get it.
G40.89 FOCAL MOTOR SEIZURE 12/28/2022 UTI (URINARY TRACT INFECTION) G40.909 EPILEPSY, UNSPECIFIED 10/12/2022 UTI (URINARY TRACT INFECTION) J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 11/3/2022 UTI (URINARY TRACT INFECTION) G40.89 FOCAL MOTOR SEIZURE 12/28/2022 HTN (HYPERTENSION) G40.909 EPILEPSY, UNSPECIFIED 10/12/2022 HTN (HYPERTENSION) J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 11/3/2022 HTN (HYPERTENSION) G40.89 FOCAL MOTOR SEIZURE 12/28/2022 NONTRAUMATIC ACUTE KIDNEY INJURY G40.909 EPILEPSY, UNSPECIFIED 10/12/2022 NONTRAUMATIC ACUTE KIDNEY INJURY J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 11/3/2022 NONTRAUMATIC ACUTE KIDNEY INJURY G40.89 FOCAL MOTOR SEIZURE 12/28/2022 ACUTE HYPOXEMIC RESPIRATORY FAILURE G40.909 EPILEPSY, UNSPECIFIED 10/12/2022 ACUTE HYPOXEMIC RESPIRATORY FAILURE J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 11/3/2022 ACUTE HYPOXEMIC RESPIRATORY FAILURE
Left arm redness and hot to touch. A follow up report received 6/4/2002 adds: Only left arm affected site.
Chronic cough starting 3-4 days after 2nd dose and he still has it as of 3/27/2021
Elevated heart rate/heart palpitations/heart racing. It occurs several times per day, regardless of physical activity. Resting heart rate went from somewhere in the 60s bpm to high 80s bpm.
Pt. received 2nd dose of Pfizer Vaccine on 1/20/21.  Pt. experienced COVID like symptoms starting 4/14/21 and tested COVID positive 4/17/21
Hx of CHF, CAD; falling asleep, excessive weight gain, fluid in lungs
Tingling on shoulder and arm; 1st dose in 2019, 2nd in 2023; This non-serious case was reported by a consumer via call center representative and described the occurrence of tingling of extremity in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2019). Concurrent medical conditions included carpal tunnel syndrome.   In FEB-2023, the patient received the 2nd dose of Shingrix (right side). In FEB-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: 1st dose in 2019, 2nd in 2023). On an unknown date, the patient experienced tingling of extremity (Verbatim: Tingling on shoulder and arm). The outcome of the tingling of extremity was not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the tingling of extremity to be related to Shingrix.     It was unknown if the company considered the tingling of extremity to be related to Shingrix.   Additional Information: GSK Receipt Date: 22-MAR-2023 The patient reported that he/she received a dose of Shingrix about 1 month ago. The patient reported that he was experiencing tingling on the same side of his body that he received the vaccine in (right). The reporter describes the tingling as ants crawling on him which starts at the top of his shoulder and down his arm. The tingling comes and goes. The patient reports that also about 1 month ago he received an IV solution for a Stress Test. The patient believes that the Shingrix vaccine he received last month was his second dose. He believes he received the first dose in 2019  The reporter consented to follow up. The reporter gave consent to follow up with HCP (healthcare profesional) (pharmacy). 1st dose taken on 2019 and 2nd dose on 2023 which lead to Drug dose administration interval too long.
skin itchy, upper back hives, red skin, throat warm monitored for 30 mins took diphenhydramine, symptoms resolved
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore arm). At the time of the report, VACCINATION SITE PAIN (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and Treatment medications are not provided.   This case was linked to MOD-2021-334628, MOD-2021-334629.
Checked the system for patient's record.  Put in patient's full name (four parts) and date of birth.  System search returned with no matching records.  Continued on as if to create new record, then the system produced a record for the patient.  I checked what vaccines were due per the system and the following were due and available to be given: Vaxelis, ProQuad, and Prevnar-13.  When going to print updated record for parent, a second system record was found, and contained two of the same vaccines - Vaxelis, ProQuad as being administered 4/28/2023.  We observed the child for 30 minutes: he did not show any reaction, and instructed mom to return here immediately if she noticed and change in the child including rash, fever, change in activity level/lethargy.
Arm red/warm in LT arm where TDAP and MCV4 were given. Physician stated it did not look like cellulitis. Mother stated that the rash started Tuesday afternoon and within the last 24hrs had spread on the arm.
Employee received influenza vaccine on 2/13/08 at approximately 2:00 pm.  She immediately reported tingling and numbness to injection site on right arm radiating to right hand.  On 2/15/08 she reported that approximately 2 hours after injection she felt chills, bodyaches, watery eyes, runny nose, cough and pain to back along side spine and cramping to pelvic region.  She was escorted to ER for evaluation and treatment.
pt recv vax 18DEC95&next day became ill;pt hosp in a comatose state&placed on a ventilator;pt died next day;death allegedly d/t skin infect;death certificate stated COD cardiac arrest,assoc w/sepsis,shock,acute renal failure,resp failure
Facial nerve paralysis left began 24-36 hours after receiving Gardisial vaccine #1 and Heptatis B vaccine #2.  There were no lesions, fever, pain, decrease in salivation, taste decrease, or vision loss.  She did not report any problems with her first Hep B vaccine. Treated with valcyclovir and prednisone.  Saw her back in the office 10 days later.  She had made a nearly complete recovery.
Already suffer from migraines. Friday started as headache turned migraines and continued to today. On Wednesday stomach started hurting, by Thursday left work early due to severe stomach pains that stayed for long time then went away & returned. Today tummy still hurts, pooping often but not diarrhea, and head is pinging
4/15- CHILLS, FEVER, BODYACHES, SWEAT POURING FROM BODY, DIARRHEA- CAME ON EXACTLY LIKE COVID DID AND VERY INTENSE. 4/16- SAME SYMPTOMS- SEEMED TO LIGHTEN UP. IN BED ALL DAY. HEADACHE AND DIZZY. 4/17- FEELING ALITTLE BETTER DURING DAY- EXHAUSTED.  4/18- WOKE UP AT 1:00ISH WITH EXTREME MIGRAINE, HEAD FELT LIKE GOING TO EXPLODE, VOMITTING. * THIS WAS WHEN I BECAME CONCERNED* USED ICE PACKS ON HEAD. WAS IN FRONT LEFT EYE, AND DOWN THAT SIDE OF HEAD , INTO MY NECK. 4/18 - MIGRAINE GONE BY 7AM, HEADACHE ALL DAY- EXHAUSTED 4/19 - SLIGHT HEADACHE THAT WONT GO AWAY- EXTREM FATIGUE 4/20- SLIGHT HEADACHE STILL STARTING TO FEEL BETTER 4/21- SLIGHT HEADACHE BUT FEELING MUCH BETTER  NOTE- HAD COVID MARCH OF 2020 EXTREMELY BAD. DOCTOR AT CLINIC WHERE I RECEIVED VACCINE ADVISED WOULD GET VERY SICK FROM VACCINE. ALL SYMPTOMS WERE EXTREMELY BAD -HOWEVER MY CONCERN IS THE MIGRAINE AND HOW BAD IT WAS AND STILL HAVE LINGERING HEADACHE. MY QUESTION IS SHOULD I RECEIVE 2ND SHOT?
Right deltoid arm swelling, redness with warmth seen in Peds ED, dx with cellulitis, on abx. Seen by PCP after ED visit. Cellulitis stable.
On 5/26/00, broke out in a rash and itched all over. Rash and itching got worse. Mom took pt to the ER on 5/28/00 and doctor prescribed prednisone dose pack for 6 days and Benadryl, which he took. Pt stopped taking Ceclor on 5/26/00. Pt no better on 5/30/00, so mom took him to MD. MD there thought rash, itching and hives were related to Ceclor allergy. Symptoms still present on 05/30/00.
Within a day or so of my first booster (10/12/2021) my neuropathy symptoms worsened significantly.  I was thinking there might be some correlation to the booster but as I was still not having major life changing symptoms, I forgot about it.  1 day after my second booster (04/20/22) my neuropathy did another abrupt increase in symptoms which this time are flirting with not being able to walk.  Obviously I am a lay person but the commonality of these events suggests something with the booster.  As to date no one I have talked with in the medical world has really defined my conditions cause, I have come to suspect some kind of autoimmune response is involved.  My reaction to the vaccine seems to support that conclusion, at least to me.  I felt it important to pass on my experience to help others with my type of disorder to be aware of the risk of this type of adverse reaction to, at least, this vaccine.
The medication being available to clinicians could have occurred due to vaccines being left in the clinic or products being returned by the clinic and not appropriately segregated when returned to the pharmacy. This was a quick change, and we all worked to communicate as quickly as possible.     Vaccine was given one day beyond date approved to administer.
Following #2 DTp pt devel t103, very lethargic & had episodes of unusual high pitch cry;
dose of expired Kinrix was administered to the patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number 24T2N, expiry date 07-MAY-2023) for prophylaxis.   On 08-MAY-2023, the patient received Kinrix. On 08-MAY-2023, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: dose of expired Kinrix was administered to the patient). The outcome of the expired vaccine used 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: 10-MAY-2023 The reporter was a Medical Assistant. The reporter consented to contact. An expired Kinrix was administered to the patient, which led to expired vaccine used.
pt had seizure activity at 20 seconds. vital signs & neuro checked, floor padding for safety
I experienced tachycardia with a HR of 120-130 and then my HR would increase to low 150's with light walking. I noticed it about 25 minutes after receiving vaccine. It seemed to subside about an hour following the vaccine injection. HR went back down to what my normal HR is 70-80's. I did not have any other symptoms and I feel fine now.
no further adverse event; her first dose was give January 14,2021. Then the second dose was given on February 12, 2021. The consumer explained she was due for her third dose today June 14, 2021; This spontaneous report was received from a 39-year-old female consumer referring to herself.  Information about the patient's pertinent medical history, concomitant medication and drug reactions or allergies was not provided.  On 14-JAN-2021, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and on 12-FEB-2021, she was vaccinated with the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) both of them for prophylaxis (route and anatomical location of administration, lot number and expiration date were not provided) (inappropriate schedule of product administration). She also reported that she was due to her third dose on 14-JUN-2021 (reported as today).  The patient was inquiring about the dosing schedule for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) since she considered her doses seem to be too close together. No adverse events were reported.
patient developed symptoms including cough, new loss of taste or smell, shortness of breath, fatigue, body aches, headache, sore throat, and runny nose on 7/31/2021.  His COVID test was positive on 8/5/2021
Information has been received regarding a case in litigation from a lawyer, a male patient of unknown age, and his spouse. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In March 2016, at age 63, the patient was administered the ZOSTAVAX by a healthcare provider (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a physician for the following injury resulting from his ZOSTAVAX use: Shingles. The outcome of the shingles is unknown. The patient claimed damages as a result of: injury to themselves, loss of consortium, loss of services, and economic losses. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to an unspecified patients of unknown age and unknown gender. On an unknown date, the unspecified patients were vaccinated with doses of improperly stored (Oka/Merck). No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
pt recvd vax the wk of 19JUN95 & devel a rash on arm where vax had been given; 27JUN95 pt had swollen glands;f/u from the pts MD indicated pt was given 2nd dose of vax 25JUL95 & exp no adverse effects;
Severe nausea; Vomiting; Muscle fatigue; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 05Mar2021 at 14:00 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, house dust mite allergy and formaldehyde allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included unspecified vitamins (unspecified). On 10Mar2021, 5 days after injection, the patient experienced severe nausea, vomiting and muscle fatigue. The events did not result in doctor or other healthcare professional office/clinic visit and 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 severe nausea, vomiting and muscle fatigue was not recovered at the time of report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Large (size of orange) swollen lymph nodes under left arm.  Used warm compresses and Advil  Still continuing as of 03/19/2021 but swelling is lessening.
She got her vaccine, had a sore arm, and then at 5:00 PM she got really, really tired.  Then around 12:30 AM she had chills, fever, headache, and an upset stomach.  She drank some peppermint tea and had some Ibuprofen around 1:30 AM.  Her fever broke within 45 minutes and went back to bed until 8:20 AM.  Since she has woken up she has had a headache, no stomach problem, and took more Ibuprofen and now feeling really tired.    Has had the COVID vaccines and flu vaccines with no problems.
sever headache itching over entire torso both began about an hour after injection. Lasted through the evening and night Took Tylenol
fainted; unconsciousness; Side effects; I had intestinal problems and have constipation; I had intestinal problems and have constipation; lack of strength; difficulty breathing; Had a lot of pain throughout my body; vomiting; Headaches; Very tired; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (fainted) and LOSS OF CONSCIOUSNESS (unconsciousness) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 300194 and 3002916) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced SYNCOPE (fainted) (seriousness criterion medically significant), LOSS OF CONSCIOUSNESS (unconsciousness) (seriousness criterion medically significant), VACCINATION COMPLICATION (Side effects), ABDOMINAL DISCOMFORT (I had intestinal problems and have constipation), CONSTIPATION (I had intestinal problems and have constipation), ASTHENIA (lack of strength), DYSPNOEA (difficulty breathing), MYALGIA (Had a lot of pain throughout my body), VOMITING (vomiting), HEADACHE (Headaches) and FATIGUE (Very tired). At the time of the report, SYNCOPE (fainted), LOSS OF CONSCIOUSNESS (unconsciousness), VACCINATION COMPLICATION (Side effects), ABDOMINAL DISCOMFORT (I had intestinal problems and have constipation), CONSTIPATION (I had intestinal problems and have constipation), ASTHENIA (lack of strength), DYSPNOEA (difficulty breathing), MYALGIA (Had a lot of pain throughout my body), VOMITING (vomiting), HEADACHE (Headaches) and FATIGUE (Very tired) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved.            No relevant concomitant medications were reported.  No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  All events are captured in one case because of the lack of clear onset date to a specific dose.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Translation received contains significant information, address, events information, product information added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  All events are captured in one case because of the lack of clear onset date to a specific dose.
aches,pain; arm pain; slight fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aches,pain), PAIN IN EXTREMITY (arm pain) and PYREXIA (slight fever) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced PAIN (aches,pain), PAIN IN EXTREMITY (arm pain) and PYREXIA (slight fever). At the time of the report, PAIN (aches,pain), PAIN IN EXTREMITY (arm pain) and PYREXIA (slight fever) had not resolved. Not Provided          Action taken with mRNA-1273 in response to the event was not applicable No treatment information was reported.
pt recv vax 11NOV97 & pt devel one round nickel sized lesion where vax was given;pt devel a cold & a fever;