chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recv vax 930AM devel sudden onset of limp,hypotonic-hyporesponsive,collapse w/grayish color & apnea @ 2PM same day;
Patient called today 11/08/2021 to see if Shingles could be attributed to COVID vaccine. I told her I would send in an adverse reaction to vaccine.  Her MD told her it was a possibility so we are following up  She says she developed a burning sensation on side of face a couple of days after vaccine and then developed a localized rash at that site.  She recognized it as Shingles from a previous outbreak.
THIS IS NOT AN ADVERSE REACTION REPORT, THIS IS A VACCINE ERROR REPORT. PATIENT WAS GIVEN A 0.5ML PEDIATRIC DOSE OF ENGERIX, AND SINCE WE DID NOT HAVE AN ADULT DOSE IN STOCK, WE GAVE AN ADDITIONAL 0.5ML DOSE. PATIENT WILL BE CONTACTED AND COME BACK IN FOR A FULL 1ML ADULT DOSE
8 minutes after vaccine, started to feel dizzy, room got quite, started to feel hot around neck ears chest, red blotchy all over and continued to get worse. Started to feel a cold sensations.  Nurse came over to assess had me sit and put legs up, rash got worse dizzines got worse, took me to a cot to lay on, had me take dose of pepcid and claritin, then decided i needed benedryl injection at 713pm. monitored my blood pressure, pulse ox and heart rate. heart rate was tachycardia. just felt off felt like something was wrong. about 30-40 minutes after benedryl injection the redness started to lighten in color. after more time of monitoring me i slowly started to feel a little better, after an hour and half or so i felt ok enough to be dropped off at home.  Today 12/27/20 i have felt very jittery, nausea chills and fatigue started around 430p.
On Monday Nov 2, 2009 received H1N1 vaccine IM. On Nov 3, 2009 reported rash on both arms. Rash was resolved after taking Benadryl.
Pt went to E.D with (R) hand numbness weakness, and swelling to site.
she had "covid arm"; a rash around the injection site; it's feverish; her face went red for several hours; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (her face went red for several hours), VACCINATION SITE REACTION (she had "covid arm"), VACCINATION SITE RASH (a rash around the injection site) and PYREXIA (it's feverish) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included INSULIN, LEVOTHYROXINE and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced ERYTHEMA (her face went red for several hours). On 11-Mar-2021, the patient experienced VACCINATION SITE REACTION (she had "covid arm"), VACCINATION SITE RASH (a rash around the injection site) and PYREXIA (it's feverish). On 02-Mar-2021, ERYTHEMA (her face went red for several hours) had resolved. At the time of the report, VACCINATION SITE REACTION (she had "covid arm"), VACCINATION SITE RASH (a rash around the injection site) and PYREXIA (it's feverish) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Another concomitant medication was cholesterol medicine.  Treatment information in response to events was not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: TCR - Event outcome was updated
Patient came in 48 hr after given ZOSTAVAX -patient reported redness, warmth and blisters around the injection site.
Chills; mild headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "Chills"; HEADACHE (non-serious), outcome "unknown", described as "mild headache". Additional Information: Optional information: No significant medical history. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Approximately 2 hours after her first COVID-19 Vaccine dose, patient began to feel right arm numbness and tingling in her hand. This progressed to right leg numbness, tingling and weakness and right lower face tingling. Patient denied any facial droop, slurred speech, confusion or dizziness. Patient reports that symptoms peaked the night of the vaccine around 9 or 10pm and had gotten better but not totally resolved.  She was advised to go to the ER and was admitted.  MRI showed an acute infarct in the left basal ganglia. CTA showed "short segment moderately severe narrowing of the M1 segment of the right MCA."  Neurologist was consulted and determined it to be coincidental that the patient had her COVID vaccine the same day.
Upon injection I immediately felt a burning sensation with administration of syringe contents.  A few hours later, discomfort to the site remained. Hives around the injection site developed, redness and warmth.  Upon awakening on 10/12/2010 at 4:00 AM, injection site with redness size of 50 cent piece.  Area continues to become larger, more inflamed, and tender and hot.
Patient reported insomnia  that night of vaccination. Fever developed the following morning along with headache. The headache persisted for at least 2 weeks, although it has been occasional and not constant.  Patient also reported nerve involvement with occasional shooting pain down both hands to the fingertips.  This was the first dose of two
BODY ACHES; CHILLS; FATIGUE; HEADACHE; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch number. No concomitant medications were reported. On MAR-2021, the subject experienced body aches. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced fatigue. On MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, fatigue, headache and body aches was not reported. This report was non-serious.
breaking into hives, hives all over body, hive come back; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (breaking into hives, hives all over body, hive come back) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unkown) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced URTICARIA (breaking into hives, hives all over body, hive come back). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Hives, at a dose of UNK dosage form. At the time of the report, URTICARIA (breaking into hives, hives all over body, hive come back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   It was reported that, hives started 24 hours after getting vaccine. She took Benadryl and when she does not take it, hives come back.
Patients guardian falsified DOB when registering for vaccination, stating the minor's DOB was 06/08/2004. Guardian consented to the vaccination. Department of Health verified with statistical records that the patients actual DOB is 06/08/2005 which made the vaccine a contraindication.  No known adverse reactions noted.
This is a spontaneous report from a contactable consumer (patient). A 34-year-old male patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 34, via an unspecified route of administration, left arm, on Sep 16, 2021, at 16:00, single dose, for COVID-19 immunisation. No medical history or allergies reported. Prior to the vaccination, patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 34, via an unspecified route of administration, right arm, on Aug 24, 2021, at 10:00, single dose, for COVID-19 immunisation. On Sep 17, 2021, at 09:00 (the following day of vaccination), patient experienced pruritis (itching all over body but primarily torso and back). It became worse during the night. It persisted for a week and slowly became more mild. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures taken as a result of the events. Since the vaccination, patient has not tested for COVID-19. The outcome of pruritis (itching all over body but primarily torso and back): recovering at the time of the report. The lot number for BNT162B2 not provided and will be requested during follow-up.
Woke up and said it felt like an elephant on his chest, still had heavy pressure at 11.. Went to pediatrician  - spirometry and heart basics, BP and pulse ox okay. Prescribed albuterol in hopes it would help in a few days. Took first dose at 1pm and feels slightly better.
Fever ranging from 100 to 103°f for 12 hours Severe Nausea for 12-15hrs Lack of appetite for 5 days Migraine 2 days
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 09-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information not provided.  Treatment information not provided.   This case was linked to MOD-2021-363771 (Patient Link).
Information has been received from a 50 year old female patient referring to herself. Concomitant therapies included bupropion hydrochloride(WELLBUTRIN), Ranitidine (reported as renidadine), levothyroxine and celecoxib(CELEBREX). The patient had raw tomatoes, contrast dyes and lobster allergy. The patient had no pertinent medical history. On 20-JUN-2018, the patient was vaccinated with M-M-R II (1 dosage form; strength, route, lot# and expiration date were not reported) on left arm for prophylaxis. Unspecified tests prior to the vaccination revealed there was no measles or chicken pox exposure. On 21-JUN-2018 (reported as a day after vaccination), the patient had nausea, flu-like symptoms and was "dry heaving foamy vomit" for 3 days. The patient said that after those symptoms went away she was feeling yucky for about a week. After vaccination she developed a golf ball sized lump at the injection site that gradually got smaller and went down to the size of a quarter a month ago and two weeks ago disappeared. The patient said she still has a dime-sized bruise with a black dot in the middle at the injection site. The patient said the bruise appeared to be fading. The patient treated the injection-site lump with cortisone creams and took acetaminophen (TYLENOL) for her flu-like symptoms. The outcome of the events was reported as recovered. The causality between the events and M-M-R II was not reported.
This spontaneous report as received from a health care worker refers to a 53 year old patient of unknown gender. There was no pertinent medical history, drug reactions/allergies reported. On 04-APR-2014 the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneously, lot h03012521 expire date 09-OCT-2013 (dose number unspecified). No concomitant medications reported. The reporter reported that the patient was administered with an expired dose of ZOSTAVAX expire date reported as 09-OCT-2013 and no adverse effects reported. The sought medical attention not reported. The product quality complaint reported as no. Additional information has been requested.
- early onset of period - fevers - chills - nausea - vomiting  - abdominal pain  - diarrhea
On 05/06/2022 I received my Covid-19 vaccine. On 08/10/2022 I started having diarrhea, sore throat, cough, extreme fatigue, sinus issues; face started getting yellow; and breakouts on face.  I tested positive on 08/11/2022 for Covid-19. Symptoms lasted about two weeks. Since Covid-19 I was diagnosed with Cold Agglutinin Disease , Monoclonal B -Cell and Lymphocytosis.
Pain at injection site, sore throat, fever, nasal congestion, runny nose, lose of taste and smell,  shortness of breath, high level blood clotting factor, pneumonia. Doctor visit on 5/26/21  OSF Virtual visit 5/27/21 , prescriptions prescribed consisted of: Montelukast , Levocetrizine DHCL , Azelastine HCI Nasal Spray , Fluticasone spray (was not administered because insurance would not allow scripts to be filled until 5/28-5/29/21). ER visit on 5/27/21 Treatment on 5/27/21-5/28/21 consisted of steroid via IV, Inhaler, antibiotic  Prescriptions prescribed: Albuterol Sulfate , Azithromycin, Prednisone
Headache, Arthralgia, NauseaVomiting, Fatigue, Chills Narrative:
Narrative:  A 74yo male with PMH of Idiopathic Pulmonary Fibrosis He received Pfizer Covid - 19 vaccine per policy and protocol First dose on February 26, 2021 and the second dose on March 19, 2021, without complications NO adverse event was reported March 24, 2021 Pulmonary Secure Messaging documentation included, the patient reported seeing twinges of blood in his phlegm x 3 days and a hack of blood the previous night. His report included sp % O2 (oxygen) dropping and staying low, ranging 48 to 68. He mentioned experiencing similar to what he had experienced back in December - early January and the need to visit the ER The system showed the patient died on March 30, 2021
Pediatric vaccine was diluted with 0.13 ml instead of 1.3 ml so the patient got a more concentrated dosage than recommended.  After 2 days, patient presented intermittent diarrhea and headache.
Gotten all the shots, still get shingles/suspected vaccination failure; Shingles every 2 to 3 months; it hurts; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 75-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Gotten all the shots, still get shingles/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles every 2 to 3 months) and pain (Verbatim: it hurts). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 12-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he/she received all the doses of shingles vaccine and still experienced shingles almost every 2 to 3 months. The patient stated that it really hurts and he/she was looking for help. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
tingling in her mouth and lips; lump in throat; dizziness; tunnel vision; shaking; headache; anaphylaxis; A spontaneous report was received from a physician concerning a 26-year-old female patient who received Moderna (mRNA-1273) vaccine and experienced Anaphylactic reaction, having tingling in patient's mouth and lips and a lump in their throat, very bad headache, dizziness, tunnel vision and shakiness.  The patient's medical history included: allergy to azithromycin and penicillin. Concomitant product use was not provided by the reporter.    On 19 Feb 2021, approximately four minutes prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 031L20A) for prophylaxis of COVID-19 infection.    On 19 Feb 2021 at 14.09, the patient had tingling in their mouth and lips and a lump in their throat. The patient's heart rate noted was 130s. The patient also reported very bad headache dizziness and tunnel vision. The patient developed shakiness which was noted on exam. The reporter reported for an anaphylaxis reaction .  The patient's Blood pressure reported was 156/80. At 14.29, the patient's Blood pressure reported was 176/87.  Treatment information provided included EpiPen (0.3mg) given Intramuscularly to right thigh at 14.22 and supplemental O2 provided. The reporter stated ambulance was called, husband of the patient was called. Reports were given to ambulance services. The systolic BP upon transport was 168.  Action taken with mRNA-1273 in response to the event(s) was Not applicable.  On 19 Feb 2021, the outcome of the events, having tingling in patient's mouth and lips and a lump in their throat, very bad headache, dizziness and tunnel vision were considered resolved and the outcome of the event, shakiness was considered not resolved.  On an unknown date, the outcome of the event, Anaphylactic reaction was considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the se events, a causal relationship cannot be excluded.
This is a spontaneous report from a contactable nurse. This is fifth of five reports by the same reporter. This nurse reported on behalf of a 3-year-old female patient who received a 5th dose of PREVNAR13 (lot number915373), intramuscularly administered into the right arm on 13APR2011. The patient had no relevant medical/drug history. Drug allergies or relevant family history was denied. Concomitant medications were not reported. On 14APR2011, the patient experienced a reaction at injection site characterized by vaccination site redness and swelling. On an unspecified date, the patient also experienced vaccination site pain. The events did not result in a doctor visit. Relevant laboratory data was not provided. The status of therapy was unknown at the time of the report. Therapeutic measures taken in response to event were unknown. The patient recovered from the events. The nurse did not wish to be contacted for additional information. Follow-up attempts completed. No further information expected. Follow-up  (28APR2011): New information reported from a contactable nurse includes: patient's date of birth and gender, lot number, medical history, product details and event details leading to the additional codes of vaccination site pain, swelling and redness, event onset dates, and outcome.
Onset of lung irritation and cough the morning after injection. Lungs feel irritated on inhale. Deep breathing provokes urge to cough. Gradually improving on its own with continuation of patient's standard daily allergy treatment of Zyrtec 10 mg bid. Patient also experienced increase in dysautonomia and hypermobility symptoms after injection, which are improving on their own.
Swollen/painful RUE following IM INJ of COVID VAC on 4/16/2021. Normal V/S, with 7/10 pain.
This AM mom found red lump on right leg at site of injection. Area inflammed, firm and warm but nontender - erythema 4x3cm, lump 2x2cm. No fever. Applied cold compress. Gave ibuprofen and benadryl. Will continue doses as needed
Pfizer-BioNTech COVID-19 Vaccine EUA: patient hospitalized for melanoma metastases leading to spinal cord compression. Underwent surgery that improved pain and symptoms. Discharged to home in good condition.
pt recvd booster dose of MR vax & on 13DEC91 recvd OPV/DT & on 18DEC91 pt exp aching bones, vomiting, & t104 to 105; the following day eyes hurt real bad; by 20DEC91 felt very sick; exp chills; dx measles;
Shortly after receiving vaccine in left deltoid, pt complained to numbing and pain near the left shoulder.  After a few minutes pt stated numbness had moved down arm and left hand was slightly darker than right hand and wrist.  Pt was advised to stay in store for observation.  After 20-25 minutes the pt stated that numbness has subsided and pt's left hand/wrist had returned to similar color as right hand/wrist.  Pt stated that she felt much better and would leave.  Pt was advised to contact pharmacy if numbness returned or if arm was tingly, or if pt had any further questions.
severe allergic reaction; blotchy rash on face; swelling face; This spontaneous case was reported by a nurse and describes the occurrence of HYPERSENSITIVITY (severe allergic reaction), RASH MACULAR (blotchy rash on face) and SWELLING FACE (swelling face) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (severe allergic reaction), RASH MACULAR (blotchy rash on face) and SWELLING FACE (swelling face). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, HYPERSENSITIVITY (severe allergic reaction), RASH MACULAR (blotchy rash on face) and SWELLING FACE (swelling face) 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.   A week later the race and face swelling reoccurred by worse causing the patient to need prednisone the HCP also emphasizes the patient did not receive any dermatological fillers.
received dose from expired vial; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received dose from expired vial) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received dose from expired vial). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (received dose from expired vial) had resolved.            Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.