chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; They accidentally gave her a yellow box instead of the blue one with grey label.; The HCP determined that it was a lower-than-authorized dose given from incorrect product; This spontaneous case was reported by a physician and describes the occurrence of WRONG PRODUCT ADMINISTERED (They accidentally gave her a yellow box instead of the blue one with grey label.), UNDERDOSE (The HCP determined that it was a lower-than-authorized dose given from incorrect product) and NO ADVERSE EVENT (No adverse event) in a 10-month-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     It was reported that patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (0.25ml dose of monovalent Moderna) on 13-Apr-2023. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine.    On 11-May-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On 11-May-2023, the patient experienced WRONG PRODUCT ADMINISTERED (They accidentally gave her a yellow box instead of the blue one with grey label.) and UNDERDOSE (The HCP determined that it was a lower-than-authorized dose given from incorrect product). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (They accidentally gave her a yellow box instead of the blue one with grey label.), UNDERDOSE (The HCP determined that it was a lower-than-authorized dose given from incorrect product) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (They accidentally gave her a yellow box instead of the blue one with grey label.) and UNDERDOSE (The HCP determined that it was a lower-than-authorized dose given from incorrect product).    Concomitant drugs were not reported.  It was reported that the vial was with a pink cap with yellow label. The HCP confirmed that the parents of the patient did not report any adverse reaction experienced by the patient.  Treatment medications were not provided.
Pt recvd 1st dose of Hep B vax on 18APR91 & mid MAY91 devel myelorediculopathy; 14JUN91 vaxed w/2nd dose of vax; @ time of report pts condition persisted but was improving;
1st Engerix B 7Jan2019, 2nd 14Mar2019; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a 38-year-old female patient who received HBV (Engerix B) (batch number GR55T, expiry date unknown) for prophylaxis.   Concomitant products included HEPATITIS B VACCINE (ENGERIX B).   On 14th March 2019, the patient received the 2nd dose of Engerix B. On 14th March 2019, unknown after receiving Engerix B, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 04-AUG-2022 Reporter's Comments: The patient received 1st dose of Engerix B on 7th January 2019. The patient received two doses of Engerix-B (both with same lot ) and a dose of Heplisav B on 1st August 2022. The reporter consent to follow up. Additional Supportive Information: The patient received 2nd dose of Engerix-B later than the recommended interval, which led to lengthening of the vaccine schedule.
Annoying ringing in bilateral ears; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Annoying ringing in bilateral ears) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced TINNITUS (Annoying ringing in bilateral ears). At the time of the report, TINNITUS (Annoying ringing in bilateral ears) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
Swollen lymph glands near underarm, injection side; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 25Feb2021 at 17:45 (at the age of 70-years-old) as a single dose for COVID-19 immunisation. Medical history included intermittent asthma. The patient had no known allergies. 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 fluticasone propionate, salmeterol xinafoate (ADVAIR) and calcium (MANUFACTURER UNKNOWN) both taken for an unknown indication from an unknown date and unknown if ongoing. On 05Mar2021, the patient experienced swollen lymph glands near underarm, injection side. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swollen lymph glands near underarm, injection side was recovering at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Later on that evening of the vaccine date my arm was swollen on the vaccine site. During all my pregnancy I never had any complications, the expected delivery date was 04/17/2021. I was induced for hypertension my doctor noticed it on 03/29/2021 and I got induced on 04/01/2021. The baby was born on 4/3/2021 & the weight was 5lbs 13oz.
Delayed cutaneous hypersensitivity.  Red, itchy, swollen and painful red rash on upper arm that appeared day after injection.   The area affected is approximately 4" wide by 6" long, most of upper arm.   Rash progressed from 4/6 through 4/8.  4/9 is starting to see improvement.
Within 10 hrs of receiving dose, Pain at injection site migrated to biceps and thighs and lower back. Foggy head and tiredness ensued.
Several minutes after vaccination on way home, mom noticed infant lifeless, head hanging down, drooling and unresponsive. Believes he was like this for a few minutes. By the time he came back to office, he was active and alert.
Pt reports some facial drooping in the right eye about 30 minutes after the vaccine. She also reports a numb sensation in the jaw followed by jaw pain. She compares it to a Bell?s palsy type reaction. She drank a lot of water and reports symptoms resolved within 30 minutes and did not return.
Migraine, nausea, and vomiting - ibuprofen, Tylenol resolved headache after several hours
Vertigo, ongoing since 04/25/21 and continuing today.  Severity has lessened, but I still experience it a few times daily.
She had 2 siezures one at night that lasted about 30 to 45 seconds and a 2nd the next morning that only last a few seconds.
Information regarding PREVNAR 13 was received from a nurse regarding an unknown number of patients who experienced swelling and redness at the injection site. The patients received a dose in 2010. Relevant medical history was not provided. Indication for PREVNAR 13 was immunisation. Product was administered in 2010. Dose regimen was 1 dose 1 time per day. Concomitant medications were not reported. The patients experienced swelling and redness at the injection site on unknown dates in 2010. The outcome is unknown. No additional information was available at the time of this report.
Information has been received from a pharmacist concerning an 86 year old male with chronic obstructive pulmonary disease and penicillin allergy and a history of cardiac failure congestive, who on 03-FEB-2010 was vaccinated with a dose of 0.5ml PNEUMOVAX 23, SC. The therapy was started since "about 5 year ago". Concomitant therapy included ZANTAC, NASONEX, lisinopril, simvastatin (MSD), potassium (unspecified) and aspirin. The patient experienced swelling and redness at the injection site that extended past his elbow. There were no labs or diagnostic tests performed. The patient visited the office for medical attention. The patient was given a dexamethasone (MSD) shot. At the time of the report, the patient had not recovered. Follow up information has been received from a pharmacist concerning the male patient who was vaccinated with a dose of PNEUMOVAX 23. The patient developed significant rash on extremity where vaccine was administered. The patient received dexamethasone (MSD) injection. The outcome was not reported. Additional information has been requested.
Pain in arm; Body aches; Very ill; Severe headache; Nausea; Chills; Joint pain; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Pain in arm), PAIN (Body aches), MALAISE (Very ill), HEADACHE (Severe headache) and NAUSEA (Nausea) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no reported medical history). Concomitant products included ATORVASTATIN for an unknown indication.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm), PAIN (Body aches), MALAISE (Very ill), HEADACHE (Severe headache), NAUSEA (Nausea), CHILLS (Chills) and ARTHRALGIA (Joint pain). At the time of the report, PAIN IN EXTREMITY (Pain in arm), PAIN (Body aches), MALAISE (Very ill), HEADACHE (Severe headache), NAUSEA (Nausea), CHILLS (Chills) and ARTHRALGIA (Joint pain) was resolving.        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.; Reporter'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.
Patient states he woke up on 11/26/10 with left side of face paralyzed. Called 911 thinking of stroke. Brought to Hospital via rescue. Worked up for stroke. Final diagnosis Bell's Palsy (Neuralgia). Started on Acyclovir and Prednisone, later developed severe pain and was started on Lyrica.
Dizziness; Tiredness; Headache; Sore arm; Feverish; Site swelling; Redness; Hot to touch; Tender; Nauseated; This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis and PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis.   On 16th September 2020, the patient received the 1st dose of Shingrix (intramuscular), Influenza vaccine Quadrivalent 2020-2021 season and PNEUMONIA VACCINE. On 16th September 2020, less than a day after receiving Shingrix and Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced dizziness, tiredness, headache, pain in arm, fever, swelling, erythema, feeling hot, tenderness and nausea. On 19th September 2020, the outcome of the dizziness, tiredness, headache, pain in arm, fever, swelling, erythema, feeling hot, tenderness and nausea were recovered/resolved.   The reporter considered the dizziness, tiredness, headache, pain in arm, fever, swelling, erythema, feeling hot, tenderness and nausea to be related to Shingrix. It was unknown if the reporter considered the dizziness, tiredness, headache, pain in arm, fever, swelling, erythema, feeling hot, tenderness and nausea to be related to Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows: The patient had all three vaccines on the same day but relates the side effects to her Shingrix vaccine only.  The side effects started the evening of the vaccination day; but all symptoms resolved within three days. The reporter did not consent to follow-up. It was unknown if the reporter considered the dizziness, tiredness, headache, pain in arm, fever, swelling, erythema, feeling hot, tenderness and nausea to be related to PNEUMONIA VACCINE.
Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with unspecified number of improperly stored PEDVAXHIB, (dose and route not provided) (lot number # L014428, expiration date: 12-MAR-2018, lot number # L006545, expired date 16-NOV-2017, lot number # L014427, expired date 09-MAR-2017 or lot number # L002867, expired date 11-NOV-2017). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
feeling off; felt very sick/don't feel too well; Out of breath; Upset stomach; uncomfortable feeling in chest; Tired; Very dizzy all the time; heart is hurting very uncomfortable; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 06Aug2021 (Lot Number: EW0186, unknown expiration; at the age of 30 years old) as dose number unknown, single for COVID-19 immunisation. Medical history reported as none. The patient's concomitant medications were not reported. The patient received the Pfizer COVID-19 vaccine shot on Friday, 06Aug2021. She experienced feeling off on 06Aug2021. It's been 4 days and symptoms are getting worse. She felt very sick and just don't feel too well in Aug2021. The patient also experienced out of breath, upset stomach, and her heart is hurting very uncomfortable in Aug2021. She has uncomfortable feeling in chest, was tired, and very dizzy all the time in Aug2021. The patient took one ibuprofen yesterday (on 09Aug2021). The patient asked what she should do now and if she should go to the ER. The patient had not yet recovered from feeling off, while unknown outcome for the remaining events.   No follow-up attempts are possible; information about batch number was already obtained.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Batch/Lot number: unknown), on 29Mar2021 as dose 2, single (Batch/Lot number: unknown), on 01Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 01Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 56 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. No known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid as treatment from 21Jun2022 to 26Jun2022. Additional information: the patient had rebound and spread to other family members without knowledge when rebounded since 30Jun2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report was received from a doctor of pharmacy refers to a patient of unknown age and gender. On 26-MAR-2013 the patient was vaccinated with an expired dose of RECOMBIVAX HB (lot# 0406AE, expiration date 25-MAR-2013, route not reported). No adverse event. Additional information has been requested.
Hives, Welts, 1 on lower leg, 2 on feet and on stomach.
Cough, headache, shortness of breath, & chest congestion, treating with mixture of lemon juice, water, apple cider vinegar, honey, & cinnamon. Also taking losengzes & sleeping a lot.
Fatigue; This case was reported by a consumer via interactive digital media and described the occurrence of fatigue in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fatigue. On an unknown date, the outcome of the fatigue was not recovered/not resolved.   It was unknown if the reporter considered the fatigue to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as an adult as per the vaccine indication. The patient received Shingrix and had fatigue. The reporter wanted to know could fatigue last for 1week.
This spontaneous report was received from a medical assistant refers to unspecified number of patients of unknown age and gender. There was no information about patients' concomitant medications, pertinent medical history, drug reactions and allergies. On unspecified dates, the patient's were vaccinated with improperly stored (Oka/Merck) VARIVAX (lot# K015992, expiration date 23-SEP-2016, dose, frequency, route and site of administration were not reported). No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
1. Bad headaches and seemed to be accompanied with muscle pain and also nausea; 2. Stomach pain in upper area, makes it hard to eat, half hungry and half want to vomit; 3. Makes me really tired. Eat boring safe food and condition goes away; 4. Got so bad that I couldn't work for a bit and I wasn't functioning very well. Saw the doctor 11/19 telehealth visit. Prescribed dexamethasone, took 4 days to kick in but barely helps. Took that for 10 days and got off of that. Tired and exhausted. Talked to the doctor again, took a different steroid 12/2 and took that for about 2 weeks. Couldn't stand side effects, now I'm just exhausted and trying to recover from steroids.
Fever, chills, generalized weakness  after vaccine 4/27 4/28 altered mental status, hypotensive, tachycardic and admitted to the hospital
2-3 day history of myalgias, arthralgias, in right knees, hips, HA occipital, neck pain, tender lymph node under left arm in axillary area, right submardibular area, increased temp (no documented fever), chills, sweats.
I?m on day four and have had every symptom in the book: fever for four days, chills, aches, headache, swollen glands, but the worst right now is the throbbing in my ears! They?re ringing and they hurt SO much. They?ll throb to temples or back to my glands. It?s so bizarre!
FELT SO BAD; This spontaneous report received from a consumer via a company representative concerned a male 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, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced felt so bad. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of felt so bad was not reported. This report was non-serious. This case, from the same reporter is linked to 20221026356.
Patient received Moderna for the first dose in location of health clinic. He was given Pfizer for his second and was not made aware he was getting a different vaccine. The mistake was noticed when I looked at his card and then followed up with clinic.
Patient reported that last year she got her high dose flu shot through the hospital in October 2018 and had no adverse reaction. After she got the FLUAD on 10-7-2019 she reports pain in her shoulder that has not subsided since 10-7-2019. She reports that her shoulder pain will wake her up in the middle of the night and gets worse when she lifts her arm. On 1-3-2020 upon hearing the patient is still experiencing substantial shoulder pain since her flu shot, the pharmacist on duty recommended the patient see her primary care physician The best health care professional to contact from the Pharmacy where the flu shot was given is Rph.
Pt received FLUZONE HD around noon on 9-12-15. At 7 pm her BP read 165/97. She took BP meds; retested later and it decreased to 108/65 at 9:45 pm. AM of 9-13-15 BP=165/97. Took BP meds-retested at 9:45 pm: 108/68. Pt BP usually not above 140/80 not normally is in the 130s at the highest per pt.
A pediatrician reported, via a company representative, than an unidentified child received Prevnar vaccine and subsequently, developed arthritis. No further information was available as of the date of this report.
Black watery diarrhea, vomiting, bloating, cramping, muscle aches, fever, confusion, black outs, fainting, excessive sleeping, disorientation/confusion, and babbling.
Right arm went numb for 2 hours, sudden headache, extreme sudden fatigue, vomiting and diarrhea.
was vaccinated on June7th with a Pediarix / exposed for 20 min to a 11.7F.; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 8-week-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number AZ472, expiry date 28th November 2022) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th June 2021, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 7th June 2021, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, 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 details were reported as follows: On 5th June 2021, from 10:15 to 10:35, the Pediarix vaccine exposed for 20 min to a 11.7 degree F. The health care professional (HCP) reported that patient was vaccinated with a this exposed Pediarix vaccine, which led to incorrect storage of drug. The reporter consented to follow up.
Developed extreme pain in my arm and shoulder muscles.  Stiffness in my hands and fingers.  The muscle pain has gone away but it still feels as if the ligaments in my shoulders are loose because it feels as if they could go out of joint.  My finger stiffness is still present.  I tried a round of hydroxychloroquine with no improvement but some affect on my eyesight and so discontinued.  Am now using CBD and celecoxib to treat.  Daily activity decreases stiffness as well.  I have under gone testing for RA which showed no sign.  All other arthritis testing has shown to be normal.