chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 27Jul2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 60 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High Blood Pressure" (unspecified if ongoing); "Obesity" (unspecified if ongoing). Concomitant medication(s) included: LOZARTAN GEO, start date: Jan2003; PRAVASTATIN, start date: Jan1999; VIT D [VITAMIN D NOS], start date: Jan2019. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which includes Paxlovid from 25Oct2022 to 30Oct2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Info has been received from an RN concerning a 10 year old white male who on 3/1/96 was vaccinated with a dose of varicella virus vaccine live. It was noted that the pt was not vaccinated at the reporter's office. On 11/17/05, the pt had a mild case of chickenpox. The pt recovered on 11/20/05. No further info is expected.
Patient presented to pharmacy with red, warm, swollen left arm on 10/24/23, 3 days after the vaccines were administered. It was recommended for her to follow up with her primary care physician because it appeared the patient had developed cellulitis.
Had shot at 5:30PM about 9:30PM.  My face was red hot and my ears.  No temp. put on ice packs no hives, called primary doctor he said to take tylenol.  Next morning calf muscle on both legs tight like in vise.  Then symptoms left date 12/16/2004.
Severe Diarrhea unable to treat with "OTC" medications. Treatment with Lomotil, Pepto Bismol and diet after being seen in Urgent care.
-Heavy muscular pain -Lymph node pain (left armpit) -Red swollen (left arm I got the shot)
14 hours post vaccine:  severe  body aches, chills, fever 102/flushing, headache, nausea. Lasted total of 24 -36 hours
4/30/21  I woke up that morning feeling very sick like I had the flu or cold. I was congested, coughing, nauseous and felt terrible.  By the next day , I was fine.
severe headache; fatigue; Shortness of breath; swelling and rash on left leg; rash on left leg; pain upper stomach area; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the right arm on 20Mar2021 at 11:00 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin and pork. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN), hydrochlorothiazide (MANUFACTURER UNKNOWN), rosuvastatin (MANUFACTURER UNKNOWN) and thyro all from unknown dates for unspecified indications and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the left arm on 27Feb2021 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 23Mar2021 at 15:00, the patient experienced shortness of breath, swelling and rash on left leg, severe headache, fatigue and pain upper stomach area. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and included treatment with inhaler and additional oral allergy medication. On 09Apr2021, the patient underwent nasal swab test for COVID-19 and the result was negative. The clinical outcome of the events shortness of breath, swelling and rash on left leg, severe headache, fatigue and pain upper stomach area was recovered with sequelae on unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
This case was reported by a physician via sales rep and described the occurrence of headache in a patient who received BEXSERO for prophylaxis. Co-suspect products included MENACTRA for prophylaxis. On an unknown date, the patient received BEXSERO at an unknown dose and MENACTRA at an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced headache. On an unknown date, the outcome of the headache was recovered/resolved. It was unknown if the reporter considered the headache to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The physician stated that she administered a dose of BEXSERO, at the same visit as MENACTRA and the patient experienced headache for a week.
Patient was given Men B vaccine and went home and later her arm was little sore and red. Some itching. Patient went to bed and woke in am with hives all over body. Patient went to Urgent Care for hives told allergic reaction to either Men B or new drug she started same day as Men B (ZOLOFT). Patient's hives cleared and she came in for follow up with Dr. to discuss reaction. Dr. felt it was from the Men B and had patient continue with ZOLOFT.
p/vax swelling & redness noted on arm;pain in rt shoulder & back area;pt felt like had a fever but did not take temp;did take APAP;
Severe arm pain. Sweeping. Redness. Area hot and firm to touch. Lasting >72hrs after injection.  Unable to lift >15lbs.
When client returned to health dept for second dose she stated she had redness, swelling, welts, itching & soreness at the site. Also developed enlarged lymph node in neck. Saw Dr. took Benadryl received a topical cream for her site symptoms. 2nd dose not given.
felt as if she had the flu; her head and throat hurts; her head and throat hurts; and that her fingers felt numb; This is a spontaneous report received from a non-contactable consumer (patient) via Medical Information Team. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number and Expiration date: not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, after receiving the 1st dose, the patient felt as if she had the flu, her head and throat hurts, and that her fingers felt numb. The patient wanted to know if the reactions were associated with the vaccine. The outcome of the reported events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a registered nurse refers to a 9 week old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 16-DEC-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M007311 (expiry date: unspecified) for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all correspondence has been received. Follow-up information indicated that suspect product with the lot# M007311 had not actually involved in the previously reported temperature excursion. Therefore, case # 1612USA012712 is being deleted from our files on generic rotavirus vaccine, live, oral, pentavalent. This is an amended report, as corrected. The reference type for the E2B number US-009507513-1610USA014706 has been changed from E2B Company Number to E2B Linked Report.; Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705: US-009507513-1610USA014706:
Pediatric patient received a vaccine from a vial which was first punctured more than 12 hours ago; Product storage error; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pediatric patient received a vaccine from a vial which was first punctured more than 12 hours ago), PRODUCT STORAGE ERROR (Product storage error ) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pediatric patient received a vaccine from a vial which was first punctured more than 12 hours ago), PRODUCT STORAGE ERROR (Product storage error ) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pediatric patient received a vaccine from a vial which was first punctured more than 12 hours ago), PRODUCT STORAGE ERROR (Product storage error ) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Pediatric patient received a vaccine from a vial which was first punctured more than 12 hours ago) and PRODUCT STORAGE ERROR (Product storage error ).    No concomitant medications were reported.  No treatment medications were reported.   Reporter did not allow further contact
He received vaccines 8-20-13 at 11:30 AM in the office and was notified by Coroner's office he had expired 8-21-13 by fax.
Initial and follow-up information has been received from a physician concerning a 67 year old female patient with no known drug reactions/allergies and pertinent medical history who on 06-MAR-2009 at 14:00 was vaccinated intramuscularly into the deltoid area with the first dose of PNEUMOVAX 23. There were no concomitant medications. On 06-MAR-2009 the patient experienced mild systemic symptoms with local reaction described as cough, headache, pain/tenderness, swelling and redness at the injection site. The patient sought medical attention on 13-MAR-2009; the patient came into the office for follow-up. At the time of reporting the patient had recovered. Additional information is not expected.
Urticaria pruritus. Diphenhydramine 50 mg prn.
had diarrhea so bad for seven days; I was so sore and sick from it; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 07-DEC-2020.   This case involves a patient of unknown age and gender who experienced had diarrhea so bad for seven days (Diarrhoea), I was so sore and sick from it (Illness), while he/she received vaccine Influenza Vaccine.   The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication was unknown.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date, the patient reported that did he consider that when he had it your immune system may have been down. That one might be eating healthier also or sleeping better or exercising more. One might had also developed some immunity due to having it ? the patient had it 2 yrs in a row also. One bout the patient had diarrhea so bad for seven days . the patient was so sore and sick from it  the patient had not had it since for several yrs and have never gotten that flu shot.  There are natural ways to boost your immune system against the flu.  It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown, at the time of reporting.  There will be no information available on the batch number for this case.  The reporter assessed the causal relationship with suspect vaccine as related.
EXTRACTION OF MODERNA VACCINE FROM THE VIAL WAS NOT CONSISTENT WITH A MODERNA TECHNIQUE  I.E. MORE THAN 20 DOSES WERE DRAWN FROM THE VIAL
Within just over half an hour of receiving it my lungs and throat started burning. Shortly after that my upper lip started to swell. Over night my lip swelled more and my face became itchy.
Severe Back pain after 2 weeks of first dose of Vaccination.Took Ibuprofen for 3 days.
Narrative:  Pt with h/o frontotemporal dementia. Caregiver states about 4:30-5:00 am she went to check on him, change him etc. States he felt very cold, then she noticed his nails were blue and he didn't seem to be breathing. Her daughter was in the apartment with her at the time. They called 911. Patient was DNR. He was reported deceased on their arrival. States that she noticed yesterday he was not as responsive. He did not seem to be in any pain. She is thankful that he was able to be home with family when he passed and that he was comfortable.
1st dose 2 years ago, never got the 2nd; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 2 years back).   On an unknown date, the patient did not receive 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: 15-Nov-2022 Reporter's comment: The pharmacist reported that the patient never got the 2nd dose. No other information was available. The reporter consented to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Presented to the emergency room with complaints of shortness of breath; dx w/ pneumonia due to COVID 19 virus; tx w/02, zinc, steroids, abx; Home w/O2
After 6 days, the left arm at the injection site, became hot and itchy with a round, firm, red spot. I am reporting that the it has grown and is still showing these signs after 3 more days.
Encephalitis; This case was reported by a consumer via interactive digital media and described the occurrence of encephalitis in a patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   Previously administered products included Shingrix (received on an unknown date), Pneumococcal vaccine (received on an unknown date) and Influenza vaccine (received on an unknown date).   On an unknown date, the patient received Tdap Vaccine. On an unknown date, unknown after receiving Tdap Vaccine, the patient experienced encephalitis (serious criteria GSK medically significant). On an unknown date, the outcome of the encephalitis was unknown.   The reporter considered the encephalitis to be related to Tdap Vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, developed encephalitis from Tdap vaacine. The patient was not walked around barefoot near manure were nails, so not worried for it.
Once he received the vaccination, he was ok and went to bed that night and slept for 48hours straight. For the next 10 days he slept for 20 hours a day, not able to get up and get out of bed not eating for days. Subsequent to that he had severe stomach issues and to this day he is not digesting things well. We went to the Pediatrician who tested everything which all came out normal, but he thinks there was an autoimmune response that was triggered. We are getting blood work done and seeing a rheumatologist. He's missed weeks of school.
This spontaneous report was received from a healthcare worker regarding unspecified patients of unknown age and gender. Information regarding the pertinent medical histories, drug reactions or allergies and concomitant therapies were not provided. On unspecified dates, the patient were vaccinated with improperly stored doses of VAQTA INJ 25/0.5 (lot # K012457, expiration date 04-JUN-2017, exact dose and route of administration were not reported). The administered doses experienced a temperature excursion of 34.3 degree Fahrenheit for 15 minutes. There was a previous excursions of 34.7 degree Fahrenheit for 15 minutes. The call was because of a "data logger". No adverse effects were reported. This is one of the two reports received from the same reporter.  Additional information has been requested.
Left arm has been hurting since vaccine was administered; This is a spontaneous case initially received from other health professional via agency (case ID: SEQ19-07051) on 26-Nov-2019, concerning a 48-year-old female patient.   The patient's current condition included hypertension. The patient's concomitant medication included amlodipine for unknown use.   On 25-Oct-2019, the patient was administered Afluria Quadrivalent [influenza vaccine, dose: 0.5 ml, batch number: P100118559, expiration date: 30-Jun-2020, anatomical location: left arm, route of administration: not reported] for influenza prophylaxis.  On the same day, after vaccination, the patient's arm had been hurting. As reported it had been hurting since the vaccine was administered.   On an unspecified date, about a month after vaccination, the patient's left arm where she received vaccine was still hurting. The patient had to change position to feel comfortable when lying down. It was reported that the patient iced it.  At the time of this report, the outcome of the event keft arm has been hurting since vaccine was administered' was not recovered.  The reporter did not provide causality criteria.  This case is linked with case 201906334 due to the same reporter.  Company Comment: Event's causality was assessed as related to the suspect product per company.; Sender's Comments: Event's causality was assessed as related to the suspect product per company.
Mom called 18MAR92 around 1230PM concerned that pt is not waking up; pt will arouse when mom wakes but not all the way;
01/22/04: Cellulitis, smallpox vaccination site with lymphangitis and left axillary lymphademopathy.  Prescribed with Evalox 400mg for 5 days, symptoms resolved 01/26/04.
Administered an expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received DTPa (Reduced antigen) (Boostrix) (batch number 4F99G, expiry date 19th August 2022) for prophylaxis.   On 29th August 2022, the patient received Boostrix. On 29th August 2022, unknown after receiving Boostrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 29-AUG-2022 Reporter's Comment: The reporter reported that the patient received Boostrix vaccine which was expired. The reporter did not have any patient information. The reporter stated that at the time of reporting repeat dose had not been administered. The reporter consented to follow up.  Additional Supportive Information: The patient received a Boostrix which was already expired, which led to expired vaccine used.
Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. On unknown dates, since 03-AUG-2015 the patients had been administered doses of (Merck) VARIVAX (lot number L012038 with expiration date of 07-APR-2017, dose, strength and route unknown), which underwent a supported temperature excursion. No adverse effects reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Patient got her 2nd SHINGRIX vaccine---she did not want to wait after the vaccine--she said she felt fine and did not have a problem with the first. She left but upon walking home, felt dizzy and fell.
Initial unsolicited report received from a consumer via social media on 10 Oct 2016. This case is linked to 2016SA188144, 2016SA188556, 2016SA188803, 2016SA188804, 2016SA188805, 2016SA188806, 2016SA188807, 2016SA188808, 2016SA188809, 2016SA188810, 2016SA188811, 2016SA188812, 2016SA188813, 2016SA188814, 2016SA188815, 2016SA188816, 2016SA188817, 2016SA188818, 2016SA188819, 2016SA188820, 2016SA188821, 2016SA188822, 2016SA188833, 2016SA188834, 2016SA188835, 2016SA188836, 2016SA188837, 2016SA188838, 2016SA188839, 2016SA188840, 2016SA188841, 2016SA188842, 2016SA188844, 2016SA188845, 2016SA188846, 2016SA188847, 2016SA188848, 2016SA188849, 2016SA188850, 2016SA188851, 2016SA191730, 2016SA191735, 2016SA191741, 2016SA191743, 2016SA191744. (Same reporter source, same vaccine). This case involves a female patient (age not reported) who was vaccinated with a dose of Flu shot (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on unspecified date. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient experienced Guillain Barre Syndrome (which nearly killed her). The patient's laboratory data and corrective treatment was not reported. The outcome of event was unknown. Upon medical review, the case was considered as serious due to important medical event: Guillain Barre Syndrome. List of documents held by sender: none. Sender's Comments: This is very poorly documented case where patient experienced Guillain Barre syndrome after influenza vaccination. However, investigation results ruling out a concurrent infection and other etiologies would be helpful to further assess this case.
Upon waking the next day I suddenly felt very ill, I was short of breath, had chills and was too weak to care for myself.  I had been diagnosed with COVID in June and was very ill with that.  This felt exactly like I did when I had COVID.   Throughout the day I ran a fever around 102.  My ability to think or care for myself was greatly impaired.  I continue to fight fatigue and brain fog.  I then developed several cold sores outside and in my mouth.  I continue to battle fatigue and weakness but am improving and now back to work.  I do not plan to get a second dose as I am afraid of a stronger reaction that would require emergency care.
Erythema multiforme-like plaques on extensor surfaces, elbows and knees beginning 12 days after vaccinia administration.
CLIENT STARYING FEELING FAINTY AFTER RECEIVING VACCINE- SKIN WAS WET TO TOUCH AND DID FAINT FOR A FEW SECOND- DID HAVE SOME DIZZINESS-B/P 118/49-P. 62 PULSE O2-99- ASSISTED HIM TO ASSURE HE DID NOT FALL- ALSO GAVE WATER TO DRINK AND OBSEVE TO ENSURE HIS SYMPTOMS DID NO ADVANCE- AFTER FIVE MINUTES HE WAS WAS FEELING BETTER-GAVE HIME A SNACK WITH A SMALL AMOUT OF SUGAR-B/P 114/59-PULSE 59-PULSE 02-99- HAD CLENT STAY FOR ADDITIONAL 20 MINUTES AND ENSURED HE WAS FEELING ACCOMADATED. FAMILY WITH CLENT- ALSO  INFORMED HIM TO CALL MD OR EMS IS FURTHER OCCURRENCE
Onset fatigue progressed to bilateral leg weakness & exhaustion. Could not sit/stand for more than 10-15 min at a time. Mild headache. Weakness to the point I could barely walk. PMD & neurologist consulted. Odd neuro symptoms - intermittent drawing of (L) foot, afebrile.