chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 14-Mar-2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 14-Mar-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 14-Mar-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 14-Mar-2022) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Mar-2022 at 10:52 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 14-Mar-2022 at 10:52 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 14-Mar-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 14-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 14-Mar-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 14-Mar-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2022-542869 (Patient Link).
Shingles when pt got vaccine; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (patient stated that she had shingles in the past before getting the vaccine).   In June 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient got Shingrix vaccine at the end of June 2020. Patient stated that she had shingles in the past before getting the vaccine.  Patient also reported that she had shingles when she got the vaccine. Patient did not clarify if it was after the 1st dose or the 2nd dose. Patient did not provide the dates of each vaccine. The patient only provided at the end of June 2020 when she got the vaccine. Patient stated she had shingles the entire year after that. Not all information was available. Lot and expiration dates were unknown. Patient sounded confuse when providing information of having shingles. She reported having them before the vaccine, when she got the vaccine and after getting the vaccine.  The patient stated she got vaccinated in June 2020 and since then she has had Shingles and it did not go away. The reporter requesting consent to follow up. For 2nd dose, refer case US2021AMR193178, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR193178:Same reporter.
5 patients of the Clinic were diagnosed with positive COVID-19 a few days after receiving the first; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of SARS-COV-2 TEST POSITIVE (5 patients of the Clinic were diagnosed with positive COVID-19 a few days after receiving the first) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced SARS-COV-2 TEST POSITIVE (5 patients of the Clinic were diagnosed with positive COVID-19 a few days after receiving the first). At the time of the report, SARS-COV-2 TEST POSITIVE (5 patients of the Clinic were diagnosed with positive COVID-19 a few days after receiving the first) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   no concomitant medication and treatment provided   This case was linked to US-MODERNATX, INC.-MOD-2021-023205 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-023205:Case crosslinked with MOD21-021925 , MOD21-021934 , MOD21-021935 , MOD21-021937 ,
COLD FEET; DIFFICULTY GETTING OUT OF BED; FEVER; FATIGUE; RATTLING COUGH WITH PHLEGM; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022 (or S022), and batch number: 1805022 (OR S022) expiry: UNKNOWN) .5 ml, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced cold feet. On MAR-2021, the subject experienced difficulty getting out of bed. On MAR-2021, the subject experienced fever. On MAR-2021, the subject experienced fatigue. On MAR-2021, the subject experienced rattling cough with phlegm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the rattling cough with phlegm, fatigue, fever, cold feet and difficulty getting out of bed was not reported. This report was non-serious.
I was feeling great the morning I got it. Next day flu like symptoms. Didn't feel quite right for the next 4-5 days.  Then I got an extreme headache on day 7, day 9 extreme muscle tightness all over, especially in the head area and I felt like I just got off a boat. I didn't have vertigo but my balance which is usually so strong was totally off.  Starting to feel a little bit better.  Went to my doctor and got a steroid shot but hoping I will start to feel like myself again soon. I am angry right now that I got it.  Stop lying to us.
Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Mild
flu; Initial information received on 10-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional..  This case involves a 60-years-old patient who experienced flu (influenza), when received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer lot number not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza) unknown latency following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown for influenza.  There will be no information available on the batch number for this case.
Breakthrough case admission after 3 vaccines  Moderna 2/15/21 lot# 015M20A;  Moderna 3/15/21 lot# 002B21A;  Moderna 11/19/21 lot# 012H2
Clay/gray colored stool; Mild nausea; Headache; Mild fatigue; Eye is swollen; Itchy eyes; Diarrhea; Runny nose; Stomach ache; Itchy Skin; Hives upper body; Rashes over the body; Pain at injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EYE SWELLING (Eye is swollen), EYE PRURITUS (Itchy eyes), DIARRHOEA (Diarrhea), FAECES DISCOLOURED (Clay/gray colored stool) and RHINORRHOEA (Runny nose) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma (Improvement) since 06-Jan-1992, Hypothyroidism since 2001, Anxiety since 1992, Anemia (Improvement) since 1974, ADHD, Food allergy (Allergic to fresh fruit, tree nuts.) and Pollen allergy. Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (AMPHETAMINE MIXED SALTS) and AMPHETAMINE for ADHD, LORATADINE and FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) for Allergy, LEVOTHYROXINE for Hypothyroidism, IBUPROFEN for Pain.    On 14-Jan-2021 at 10:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced EYE SWELLING (Eye is swollen), EYE PRURITUS (Itchy eyes), DIARRHOEA (Diarrhea), RHINORRHOEA (Runny nose), ABDOMINAL PAIN UPPER (Stomach ache), PRURITUS (Itchy Skin), URTICARIA (Hives upper body), RASH (Rashes over the body) and INJECTION SITE PAIN (Pain at injection site). On 15-Jan-2021, the patient experienced FAECES DISCOLOURED (Clay/gray colored stool), NAUSEA (Mild nausea), HEADACHE (Headache) and FATIGUE (Mild fatigue). On 15-Jan-2021, EYE SWELLING (Eye is swollen), EYE PRURITUS (Itchy eyes), DIARRHOEA (Diarrhea), RHINORRHOEA (Runny nose), ABDOMINAL PAIN UPPER (Stomach ache), PRURITUS (Itchy Skin), URTICARIA (Hives upper body), RASH (Rashes over the body), INJECTION SITE PAIN (Pain at injection site) and HEADACHE (Headache) had resolved. On 17-Jan-2021, FAECES DISCOLOURED (Clay/gray colored stool), NAUSEA (Mild nausea) and FATIGUE (Mild fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Loratadine-D and a dose of Flonase and ibuprofen were reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: Patient demographic added. Patient relevant history and concomitant medications were added. The outcome of the events from recovering to recovered updated. New events (hives, injection site soreness, nausea, fatigue, headache) were added.
Fever and Chills. Headache. Aches and pains all over my body, especially the injection site lasting until 10/8/2012. Nausea and stomach cramps lasting until 10/8/2012. Fatigue and weakness lasting until 10/8/2012. Irritability lasting until 10/8/2012.
Positive Covid-19 test on 08/05/2021.   Horrible case, but recovered on 08/21/2021. On 08/25/2021 the pharmacist and administrating nurse encouraged vaccine knowing I had just recovered and was tested positive a few weeks earlier.  I was front page in the local newspaper just the week prior for surviving it.  Everyone knew this and I wrote my positive test date on the consent form. 36 hours after vaccination on 08/28/2021 I woke up at 4:30am shaking uncontrollably and with every heart attack symptom for some time with .  Tried to bring heart rate down myself with 3mg Klonopin and after two hours of symptoms went to the ER.   Heart rate ranged between 123 and 175 while at rest.  Had chest pain and tachycardia for three weeks after event.  Currently can not walk half a mile without heart rate going up to 189 and feeling faint with pounding chest.
A report was received from a health care professional on 12/12/03 concerning two vaccinees of unknown sex and aged between 2 and 3 years who inadvertently received Fluvirin on the same day. On 12/12/03, two vaccinees inadvertently received Fluvirin. At the time of the report no adverse events had been reports. There was insufficient information to determine the reporter's causality assessment. Update 3/1/04: Follow up information received from a health care professional indicated that a 3.5 year old male vaccine inadvertently received Fluvirin on 12/12/03. No adverse events have been reported to date. No follow up pending, all information received.
She self-reports having "SVT" (patient is a nurse) and feeling flushed and itchy. She resolved this and then almost two weeks later she a large area of erythema, swelling and itching over the vaccine site with axillary pain and itching.  She had been taking some OTC antihistamine with some relief. She was advised not to take the second shot. This was at her appointment on 1/12/2021.
pt recv vax 8NOV95 & 23APR96 pt exp chicken pox (multiple lesions) & itching;no further details were provided;
Patient was given the vaccine at 15 years old, which apparently at that time was below the minimum permitted age. The age has since been reduced to 12 years old. Our corporate office has requested that we submit a report. No adverse reactions were reported, however the vaccines provided on 04/03/2021 and 04/25/2021 are to be reported as given in error.
TDAP Vaccine (administered at 32 weeks of pregnancy): Injection site enlarged to three inch diameter/swelling/pain/redness (10 days); Nausea (1 day); Sore throat (3 days); Severe cold symptoms (aches, cough, congestion) (8 days).
she had a side effect related to the moderna vaccine; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (she had a side effect related to the moderna vaccine) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (she had a side effect related to the moderna vaccine). At the time of the report, IMMUNISATION REACTION (she had a side effect related to the moderna vaccine) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. It was reported that the patient had first, second and third dose of moderna vaccines and a Pfizer bivalent 5th vaccine. No treatment information was reported.
Redness, swelling, itching and burning around eyes mouth and neck .It is not hives or a rash, looks and feels like burns. Took Prednisone injections and oral tablets, cortisone cream, as well as several antihistamines. Also saw an allergists, given same treatment. This will not go away, only gets somewhat better as long as I am taking large doeses of medication. Has not completely gone away. I have photos of each episode. I am very concerned there may be scaring.
Controlled blood sugar went from readings of 77 to 319. Sick, nauseous, shaky, confused.   All within 18 hours. Went to hospital.
I had diarrhea the first day and injection site pain. On Friday 4/23 I woke up extremely fatigued.  By mid day I had a fever, chills, tiredness, joint and muscle pain, nausea and just felt lethargic and awful all at the same time.
This spontaneous report as received from a nurse concerning to a 1 year old male patient. Patient's concurrent conditions and relevant medical history was not reported. On 11-NOV-2014, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX (lot number: K005185 with expiry date of 10-APR-2016). Concomitant medications were not reported. The temperature excursion for (Oka/Merck) VARIVAX was a supported excursion with long term stability data. No adverse symptoms were reported. The nurse reported that there have been no reports of adverse events following administration and there was no need for revaccination. The outcome of the events was unknown. The causality of the events with (Oka/Merck) VARIVAX was not reported. This case is linked to #1411USA007182 via same reporter link. Additional information has been requested.
Patient's mother observed a typical injection site reaction day 1 after vaccine administration (date of administration being day 0), mother gave ibuprofen to help with discomfort. On they morning of day 2, small hives were observed along patients chest, not itchy, just visible. No medication was given, watch and wait. On day 3 the rash spread throughout torso, abdomen and shoulders. Mother administered pseudoephedrine and diphenhydramine.  Pharmacy was  notified on day 3 at  about 12:00 pm, and VAERS report was promptly initiated.
This case was reported by a consumer via call center representative and described the occurrence of hives in a 21-year-old female patient who received FLULAVAL QUADRIVALENT 2018-2019 season for prophylaxis. On 24th September 2018, the patient received FLULAVAL QUADRIVALENT 2018-2019 season. On 27th September 2018, 3 days after receiving FLULAVAL QUADRIVALENT 2018-2019 season, the patient experienced hives, facial swelling, hand swelling and ankle swelling. The patient was treated with prednisone and DEPO-MEDROL. On an unknown date, the outcome of the hives was not recovered/not resolved and the outcome of the facial swelling, hand swelling and ankle swelling were recovered/resolved. It was unknown if the reporter considered the hives, facial swelling, hand swelling and ankle swelling to be related to FLULAVAL QUADRIVALENT 2018-2019 season. Additional details were reported as follows: The patient had never had a side effect to a vaccine before. The patient had a dose of FLULAVAL QUADRIVALENT and three days later she broke out with hives. The patient had been to several physicians so far and had taken Prednisone. The hives resolve while she was on Prednisone, but they came back worse afterwards. The patient now had swelling of her face and hands and down to her ankles. The patient took DEPO-MEDROL and it lasted for 2 weeks. It did appear that an adverse event was reported during the call. The reporter was consented to follow up.
ITCHING ALL OVER, DEEP ITCH ON THE  HANDS, FEET, STOMACH, HEAD, LEGS; FLU LIKE SYMPTOMS; HURTING ALL OVER/ACHY; MUSCLE ACHES; FEVER (DID NOT TAKE TEMP); NAUSEA; TIRED; SORENESS TO LEFT ARM INJECTION SITE; LIGHT HEADED; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included arthritis neck shoulders, alcohol use, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient had no history of drug abuse or illicit drug use. takes muscle relaxer and med to lose weight.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095 expiry: UNKNOWN) dose was not reported, administered on 16-JUL-2021 for prophylactic vaccination. Concomitant medications included lidocaine for arthritis. On 16-JUL-2021, the subject experienced light headed. On 16-JUL-2021, the subject experienced flu like symptoms. On 16-JUL-2021, the subject experienced hurting all over/achy. On 16-JUL-2021, the subject experienced muscle aches. On 16-JUL-2021, the subject experienced fever (did not take temp). On 16-JUL-2021, the subject experienced nausea. On 16-JUL-2021, the subject experienced tired. On 16-JUL-2021, the subject experienced soreness to left arm injection site. On 18-JUL-2021, the subject experienced itching all over, deep itch on the hands, feet, stomach, head, legs. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride/zinc acetate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle aches, fever (did not take temp), nausea, tired, light headed, itching all over, deep itch on the hands, feet, stomach, head, legs, soreness to left arm injection site, flu like symptoms, and hurting all over/achy. This report was non-serious.
DTaP-IPV portion of the pentacel was reconstituted with quadracel, instead of the Hib diluent supplied with no reported adverse event; DTaP-IPV portion of the pentacel was reconstituted with quadracel, instead of the Hib diluent supplied, giving the patient an extra dose of the DTaP-IPV with no reported adverse event; Initial information received on 29-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 1 years old male patient who had vaccines DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] and DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] and it was reported dtap-ipv portion of the pentacel was reconstituted with quadracel, instead of the hib diluent supplied with no reported adverse event and dtap-ipv portion of the pentacel was reconstituted with quadracel, instead of the hib diluent supplied, giving the patient an extra dose of the dtap-ipv with no reported adverse event   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 28-Jul-2022, the patient received a  dose of 0.5 ml of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot UJ673AA, expiration date: 27-Apr-2023, via intramuscular route in the left thigh as Immunisation On an unknown date, the patient received a  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE lot number not reported in unknown administration site as Immunization. Lot number was requested.  On 28-JUL-2022 the dtap-ipv portion of the pentacel was reconstituted with quadracel, instead of the hib diluent supplied with no reported adverse event (product preparation error) and dtap-ipv portion of the pentacel was reconstituted with quadracel, instead of the hib diluent supplied, giving the patient an extra dose of the dtap-ipv with no reported adverse event (extra dose administered) same day following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE and (unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE. Action taken was not applicable.  It was not reported if the patient received a corrective treatment for all the events  At time of reporting, the outcome was Unknown for all.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This spontaneous report was received from a registered nurse regarding an unspecified number of patients of unknown demographics. No concurrent condition and historical medication was reported. On an unknown date the patients were vaccinated with improperly stored (Merck) PROQUAD, .5 ml, subcutaneous. No adverse event was reported. No product quality complaint was involved. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Pt recvd Engerix-B on 30APR90, 29MAY90 & 25OCT90 subsequently was found neg anti-HBS p/3 doses @ 1mo, 2mo, & 6mo intervals;
pt stated a week after vax her left arm started itching and burning and swollen around injection site.  Pt states her arm is better and she contacted her PCP and they advised her to call us.