chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 13 year old female patient who on an unspecified date was vaccinated IM with a dose of Gardasil vaccine (Lot number not provided). It was reported that the patient may have received other vaccines within the same visit, but specifics unknown. The reporter indicated the patient who received the vaccine had fainted. Patient was fine before leaving the office. The patient outcome was recovered. No product quality complaint was involved. Additional information has been requested. Inital and follow-up information has been received from a physician concerning a 13 year old female patient with no known allergies who on 14-NOV-2007 was vaccinated IM with a third dose of HPV vaccine (lot # 659435/1255U). It was reported that the patient started her first injection on 08-MAY-2007 and the date of second injection was not mentioned. The reporter indicated the patient who recieved tha vaccine had fainted. In follow-up information it was reported that the patient stated that she was light headed and little dizzy after the vaccination. He blood pressure was taken and had her lay down and watched her. Syptoms persisted approximately thirty minutes. Patient was fine before leaving the office. The patient outcome was recovered. No product quality complaint was involved.
red pin-point rash on both arms & legs none on trunk of body-No medical treatment-pt applied topical cream to dec itching;
pt recv vax 3SEP97 & pt was c/o pain around inj site on noc of 3SEP97 & c/o aching on whole side of body where vax given following day 4SEP97;no redness or fever reported;referred to call MD & given toll free reporting phone number;
This spontaneous report as received from a physician refers to a patient of unknown age. On 07-NOV-2013 the patient was vaccinated with ZOSTAVAX (lot # J002242, expired date 21-MAY-2014, 0.65 ml, subcutaneous). It was reported that the dose of ZOSTAVAX was administered post temperature excursion of 30F over 10 days or 240 hours. No adverse effects reported. The outcome and action taken were not provided. The patient did not seek any medical attention. This is one of several reports received from the same source. Additional information has been requested.
Ringing in the ear all the time; This is a spontaneous report from a non-contactable consumer, the patient. A 65-years old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on an unknown date in Mar2021 (at the age of 65-year-old) as a single dose for COVID-19 immunisation. The patient was allergic to sulfa. Concomitant medications included lexapro (MANUFACTURER UNKNOWN) from an unknown date and atarax (MANUFACTURER UNKNOWN) from an unknown date and for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 30Mar2021, the patient experienced ringing in the ear all the time. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event ringing in the ear all the time was not resolved.  No follow-up attempts are needed. No further information is expected.
"Covid arm" - the evening of my vaccine  I developed a red rash & hard bump around injection site that was very tender;  the next day after my vaccine, my underarm lymph nodes in my left arm became slightly swollen & tender and remained so for about a week
vomited water all day long.  Headache the night before after this second booster vaccine.
Shivers; This case was reported by a consumer via call center representative and described the occurrence of shivers in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 6th February 2020, the patient received the 2nd dose of Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced shivers. On an unknown date, the outcome of the shivers was unknown.   It was unknown if the reporter considered the shivers to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected adult as per vaccine indication.  The patient experienced Shiver after receiving 2nd dose of Shingrix.
Sore arm, fever , chills joint pain, body aches, swollen lymph node under left arm, pounding headache, tiredness
Muscle spasm in right thumb, constant involuntary twitching, pain in left thigh
Pain immediate on insertion, extreme soreness and tightness. It's been nearly 3 months and I cannot sleep on my right side, if I happen to do so my arm is in excruciating pain and feels heavy. I have a difficult time daily to lift my arm and perform certain movements. Specifically when trying to take my shirt off. My arm hurts.
I had a bad red sore throat & I had a very bad sinus congestion and so I got tested & was I was positive Covid-19.
This initial spontaneous report was received from a medical assistant referring to multiple patients of unknown ages and genders. There was no pertinent medical history or drug allergies/drug reactions described. The reporter stated that from 29-SEP-2015 through 30-SEP-2015, the patients received improperly stored doses of ROTATEQ oral solution (lot # K020181 with expiration date 24-JUN-2016, lot # K019370 with expiration date 16-JUL-2016, lot # L000433 with expiration date 09-JUL-2016 and lot # K022995 with expiration date 22-JUL-2016; dose was not provided). There was no concomitant medication. Product quality complaint was not involved. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Since receiving the first vaccine I first had arm pain, but only for the first day or two.  Then a couple of days later I realized that I had low grain headaches (which never have), sneezing, running nose, and feeling flushed.  What clued me in to paying more attention to these symptoms:  I found myself two days in a row opening windows (in winter) because I was feeling hot/flushed and since I almost never have a fever, it took me a day to figure out that the hot/flushed feeling, plus other symptoms was probably a low grade reaction to the vaccination.  A week later, I remain stuffed up but the headache is going away and I have not felt flushed yesterday or today.
cellulitis due to immunization -redness slt edema warm to touch (back of R thigh)
This spontaneous case was received from a medical assistant referring to a 6 month old patient of unknown gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date, the patient was administered an unspecified dose of ROTATEQ (lot: N021026, expiry date: 24-FEB-2019) that was improperly stored (product storage error). The vaccine was exposed to a temperature of 74F for 5 hours. The call was because of a digital data logger. There was no previous temperature excursion. No adverse effects reported. This is one of the two reports received from the same reporter.
Myalgia & Fever Narrative: missed work following the second dose due to the above symptoms
Patient had pain and swelling in her left arm about 5 hours after  the injection, said it did not hurt when it went in. Patient stated it was a significant amount of pain. A few days later was still a little swollen with some yellow discoloration. Spoke with the patient on 02/12/2020 she said it was all healed.
The vial was stored to the refrigerator on 06-Feb-2023 and administered on 19-Mar-2023 and 20-Mar-2023; No adverse event; Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used), PRODUCT STORAGE ERROR (The vial was stored to the refrigerator on 06-Feb-2023 and administered on 19-Mar-2023 and 20-Mar-2023) and NO ADVERSE EVENT (No adverse event) in an adult 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. 066H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In March 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In March 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was stored to the refrigerator on 06-Feb-2023 and administered on 19-Mar-2023 and 20-Mar-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used), PRODUCT STORAGE ERROR (The vial was stored to the refrigerator on 06-Feb-2023 and administered on 19-Mar-2023 and 20-Mar-2023) 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 EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (The vial was stored to the refrigerator on 06-Feb-2023 and administered on 19-Mar-2023 and 20-Mar-2023).    No concomitant medications were reported. It was unknown if Patient received any other vaccine in the 4 weeks prior to COVID-19 vaccine. Pharmacist would like to know if an expired dose is administered. HCP informed the vaccine was administered after the 30-day Use by Date of 08-Mar-2023 to 2 patients on 2 different dates. No concomitant medication information was provided. The product was reported as Bivalent 6 years and older and vial size was reported as 2.5 ml. It was reported that Lot 066H22A was stored to the refrigerator on 06-Feb-2023 Vaccine was administered on 19-Mar-2023 and 20-Mar-2023 It was reported that the vial did not undergo temperature excursions. No treatment information was reported.    This case was linked to US-MODERNATX, INC.-MOD-2023-716565 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716565:
I/m 41 and have never had early or late periods. I'm not on birth control. I got the second dose the day I started my period on May 21st. I got my next period early and twice in June.   Also, after the second dose, I was down for three days with severe chills, a fever and severe body aches.
MENACTRA ADMINISTERED CORRECTLY IM IN LEFT DELTOID. DEVELOPED PAIN, LOCALIZED TENDERNESS WITH FAINT ERYTHEMA/TACTILE WARMTH IN DELTOID MUSCLE. NO SYSTEMIC SYMPTOMS. TREATED WITH WARM SOAKS, IBUPROFEN, LUE ELEVATION, REST.
Customer sat down in waiting area and then passed out and fell on the floor.  He quickly regained consciousness and was pale and sweating with low blood pressure and heart rate.  Paramedics evaluated him and he refused to go to the hospital.  His blood pressure returned to normal.
pain in the arm; headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain in the arm) and HEADACHE (headache) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 experienced VACCINATION SITE PAIN (pain in the arm) and HEADACHE (headache). At the time of the report, VACCINATION SITE PAIN (pain in the arm) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Treatment medications were not reported.
Pain and Swelling, at injection site.   Increased severity and  frequency  of head , neck, and facial neurological ticks
Information has been received from a physician concerning a female with no pre-existing allergies, birth defects or medical conditionswho in approximately 2008, "about 2 years ago" was vaccinated elsewhere with GARDASIL IM three doses (therapy doses and site unknown). On 24-MAY-2010 the pap smear showed LGSIL (Low Grade Squamous Intraepitheliel Lesion) and high risk HPV (human papilloma virus). At the time of this report, the patient's outcome was unknown. The reporting physician considered these adverse events to be other important medical events. This is one of several reports received from the same source. No further information is available.
Left leg red and swollen at the sight of injection with fever in the area. Complained of lots of pain.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history information was reported.     On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore arm). At the time of the report, VACCINATION SITE PAIN (sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  Treatment details included Tylenol.   This case was linked to MOD-2021-016905, MOD-2021-016866 (Patient Link).  This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Feb-2021 and was forwarded to Moderna on 18-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history information was reported.     On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore arm). At the time of the report, VACCINATION SITE PAIN (sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  Treatment details included Tylenol.   This case was linked to MOD-2021-016905, MOD-2021-016866 (Patient Link).
4th dose Engerix-B administered to a 3 year old; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 3-year-old male patient who received HBV (Engerix B) (batch number ZT72F, expiry date 15th December 2024) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st March 2023, the patient received the 4th dose of Engerix B and Engerix B Pre-Filled Syringe Device. On 1st March 2023, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 01-MAR-2023 Reporter's comment: The reporter consented to follow up. Additional supportive information: A 4th dose of Engerix B was administered to a patient, which led to extra dose administered.
Inconsistent Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Inconsistent Dizziness) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 009C21A) for COVID-19 vaccination.     No medical history information was provided.  Concomitant products included METOPROLOL and AMLODIPINE for Hypertension, COLECALCIFEROL (VIT D [COLECALCIFEROL]), ASCORBIC ACID (VIT C) and MULTIVITAMIN [VITAMINS NOS] for Supplementation therapy, LORAZEPAM for an unknown indication.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced DIZZINESS (Inconsistent Dizziness). The patient was treated with MECLIZINE HCL ongoing since an unknown date for Adverse event, at a dose of 25 milligram. At the time of the report, DIZZINESS (Inconsistent Dizziness) outcome was unknown. Not Provided          The action taken with mRNA-1273 with the event was considered as not applicable.   This case was linked to MOD-2021-237493 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Non significant follow up received; action taken changed to Not applicable., generated the narrative
the day one and one and a half were absolutely awful; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE) (Batch/Lot number: unknown). Relevant medical history included: "Asthma" (unspecified if ongoing), notes: Verbatim: Asthma; "Bipolar disorder" (unspecified if ongoing), notes: Verbatim: Bipolar disorder; "Obesity" (unspecified if ongoing), notes: Verbatim: Obesity; "immunocompromised" (unspecified if ongoing), notes: I am immunocompromised because I am on lot of medication and high risk. Concomitant medication(s) included: ADVAIR; PRISTIQ; LEUCOVORIN CALCIUM; VALIUM; AMBIEN; ZAPONEX; ADDERALL; SINGULAIR; ABILIFY. Vaccination history included: Flu vaccine (I had the Flu vaccine probably about a month earlier), for immunization. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "the day one and one and a half were absolutely awful". Additional information: Patient don't have that. can give the pharmacy information and they will be able to provide it to you. That is on the vaccine card. My spouse has that. I don't have that information on hand. My doctor provided me that. I do not know that. It was the, they would know. I am not sure if I am actually at the right place. to report an adverse event following a booster vaccine. Would that be able to work for you or should I go to another website. one of the outlier' of groups you could say, and that I was affected with COVID prior to the vaccine being on the market. So that makes me sort of a 'quarter' case here. I received Pfizer vaccine across this spectrum. The first dose was, the day one and one and a half were absolutely awful. That is not really what's important. Reporter stated, "During the first vaccine. had side effects.  Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101545735 similar report from same reporter
Shots given in same Left arm. Arm became very sore then intense itching and burning continuing for 1 week (7-10 days). Pt self-treated w/Benadryl. Also itching torso for 3 days.
Heavy Headache 1055, Left hand cramp 1120, numbness of the face 1130
She got dizzy with the second dose of the covid vaccine, had headaches with first two doses of covid vaccine; She got dizzy with the second dose of the covid vaccine, had headaches with first two doses of covid vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 50-year-old female patient received bnt162b2 (BNT162B2), administration date 03May2021 (Lot number: EW0176) at the age of 50 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "COPD", start date: Mar2021 (unspecified if ongoing), notes: Patient Medical start date: Mar2021, Patient Medical comments: Verbatim: COPD; "Covid-19", start date: Feb2021 (unspecified if ongoing), notes: She had Covid back in February prior to the vaccine. She got vertigo bad with covid virus when she had it back in Feb2021.; "She got vertigo bad with covid virus", start date: 2021 (unspecified if ongoing), notes: She got vertigo bad with covid virus when she had it back in Feb2021.; "had surgery in Apr2021", start date: Apr2021 (unspecified if ongoing), notes: had surgery in Apr2021. There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose: 07Apr2021 at 08:40am, Lot: ER8729, Expiration: unknown, Clinic Site: (withheld)), administration date: 07Apr2021, when the patient was 50 years old, for Covid-19 immunization, reaction(s): "had headaches with first two doses of covid vaccine".  The following information was reported: HEADACHE (non-serious), DIZZINESS (non-serious) all with onset 2021, outcome "unknown" and all described as "She got dizzy with the second dose of the covid vaccine, had headaches with first two doses of covid vaccine".  Additional Information: Prior vaccination, the patient did not receive any vaccination within 4 weeks. The patient had no relevant family medical history. No relevant tests were done. She had Covid back in February prior to the vaccine. She got vertigo bad with covid virus when she had it back in Feb2021 and was prescribed meclizine by her doctor. States she took meclizine after experiencing dizziness after the covid vaccine and it did not help a whole lot. She got dizzy with the second dose of the covid vaccine, had headaches with first two doses of covid vaccine.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101573064 similar report from same reporter;US-PFIZER INC-202101594340 1st dose, BNT162B2
Day 2 -goose egg sized lump right upper arm, redness, swelling, warmth Day 3-rash, lump, swelling upper right arm, warmth Day 4-pain in entire arm, extending into right shoulder blade and neck, numbness/tingling into hand fingers, swelling, warmth, lump at injection site
W/in 24 hrs of vax pt hospitalized w/sudden fever of 103 & prolonged generalized tonic/clonic sz lasted 45min & resolved p/tx w/diazepam also Phenobarb which had to be discontinued because of rash;
5 minutes after the injection I developed tinnitus in both ears. This has continued on since the injection.  It varies in intensity but is constantly there. I had never experienced tinnitus prior to the shot.
Fever 102 Every bone/joint ached light headed (Lasted 24 hours)
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, the patients were vaccinated with improperly stored doses of PROQUAD lot# M049122 with expiration date 13-JUN-2018 (therapy type: RHA), lot# N010866 with expiration date 01-OCT-2018 (therapy type: RHA) and lot# N014759 with expiration date 08-NOV-2018 (therapy type: RHA). The vaccine was reconstituted with properly stored sterile diluent. The vaccines underwent a temperature excursion between 15 and 46 degrees Fahrenheit for 2 hours and 13 minutes. Digital data logger was used to record the excursion. No previous temperature excursion was noted. No adverse event was reported. This is one of two reports received from the same source. Sender's Comments: US-009507513-1709USA000887.