chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The evening of 4/09/2021, I had body aches and tiredness, along with a very sore arm. On 4/10/2021, the vaccination site was swollen, hot and had a rash. I treated it with a steroid cream through 4/13/2021. From 4/10/2021 through 4/14/2021, I experienced  multiple symptoms, e.g., a slight fever of 99.9 F, nausea, and tiredness. As of 4/14/2021, my vaccination site is still swollen some and sore but the rash has disappeared. I am beginning to feel much better but felt it was worth providing you with the data for your records.
Pt c/o severe HA approx 5 min post vaccine, then c/o nausea within 10 min.  Took patient to ED.  She was given IV benadryl and reglan and CT head done (negative). VS in ED: 163/97, 85, 12, temp 98  The following day, 10/12/21, patient reports - injection site "red and swollen like a golf ball....stomach upset all day and pain in entire left upper side, especially under arm." c/o mild headache
IMPROPER STORAGE OF VACCINE.  PATIENT DID NOT HAVE ANY ADVERSE REACTIONS
The injection hurt immediately. It hurt the next day and the pain has never subsided. The pain is most intense at the injection site. My shoulder has hurt on the left side towards my neck, through my shoulder. I returned to Pharmacy and told the tech about the pain a couple of days later. He recommended icing the site. It has been 3 1/2 months and I don't have relief. I occasionally take a TYLENOL to lessen the pain. My husband is tired of me complaining. I am tired of complaining.
This spontaneous report as received from a pharmacist refers to an over 65 year old male patient. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX23 (route, dose and lot number not provided). On an unknown date after vaccination with PNEUMOVAX23, the patient experienced community acquired pneumonia and was hospitalized. It was mentioned that the patient was on a cruise and was admitted to an unspecified hospital in another country for treatment. The patient's outcome was reported as recovered, on an unspecified date. Community acquired pneumonia was considered to be life threatening by the reporter. Additional information has been requested.
diagnosed with shingles; 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 female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Dec2022 at 17:00 as dose 4 (booster), single (Lot number: GH9703) at the age of 40 years, in right arm for covid-19 immunisation. The patient's family history included: "shingles" (unspecified if ongoing), notes: None, but my dad got shingles pretty early too (like 46?). There were no concomitant medications. Past drug history included: Cipro, reaction(s): "Allergies: Cipro". Vaccination history included: Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Manufacturer unknown), for COVID-19 immunization, reaction(s): "COVID-19"; Covid-19 vaccine (DOSE 2, SINGLE, Manufacturer unknown), for COVID-19 immunization, reaction(s): "COVID-19"; Covid-19 vaccine (DOSE 1, SINGLE, Manufacturer unknown), for COVID-19 immunization, reaction(s): "COVID-19". The following information was reported: HERPES ZOSTER (non-serious) with onset 09Dec2022 at 03:00, outcome "recovering", described as "diagnosed with shingles". The event "diagnosed with shingles" required physician office visit. Therapeutic measures were taken as a result of herpes zoster.  Additional information: Report about covid treatment: Yes. Dose received: More than 3. No other vaccine in four weeks. No other medications in two weeks. Adverse event: Two days after her second booster (4th shot, the newer one), She noticed a small rash on her left flank. (That would be her butt.) today, Monday, 5 days after the shot, the rash got pretty painful so she went to a doctor and got diagnosed with shingles. AE treatment: Too late to take antiviral, so just pain relievers. No covid prior vaccination and no covid tested post vaccination. Known allergies: Cipro. Other medical history: None, but her dad got shingles pretty early too (like 46?).
Patient reecived Zoster Vaccine on 6-11-14. Returned to clinic on 6-13-14 complaining of a rash, swelling, and warmth at the injection site. Was told to take ADVIL around the clock until symptoms resolve.
No adverse event; Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) in a 91-year-old female patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used).    Patient's age was reported as 91 Year 0 Month.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.  ID: 80777027399
Patient reported feeling a tingling in her jaw about 15 minutes after administration. She stayed under observation for a while and was told to call her doctor if any symptom progressed. She was called at 7:00pm and said she had also experienced a slight tightness in her throat. She took one dose of Benadryl. She called her primary care MD and they advised her to go to the ER if the symptoms worsened.
Initial health care professional report received on 12 Mar 2010: This child received FLUVIRIN (batch number 102147P1) 0.25ml dose intramuscular inadvertently on an unspecified date. No other adverse event was reported.
Subsequent to receiving vax pts  arm was red and edematous with blisters. Pt was referred to physician for follow-up.
Patient was given 0.2ml of the 30mcg formula instead of 0.2ml of the 10mcg formula.
Information has been received from a registered nurse referring to an unknown number of patients of unknown age and gender. Concurrent conditions and medical history of the patients were not reported. On unknown dates, the patients were vaccinated with doses of GARDASIL (lot # K006124, expiry date: 02-FEB-2017)(lot# K009482, expiry date: 06-MAR-2017)(dose and route unspecified), which had been improperly stored under 10 degree centigrade for 72 hours, and later under 1 degree centigrade for 8 hours. Other suspect and concomitant therapies were not reported. This is one of several reports received from same source. Additional information has been requested.
vials that were put in the fridge and after that refrozen and thawed again; No Adverse Event; 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jan-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. On 11-Jan-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided      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 POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and PRODUCT STORAGE ERROR (vials that were put in the fridge and after that refrozen and thawed again).    No concomitant medication was provided by reporter. Nurse reported an adverse event 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again 100 adults male patients were involved and date of administration was 11-Jan-2023, lot numbers were unknown to the HCP. No treatment medication was provided by reporter. This case is for 76th patient out of 100 male patients reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-697752 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2023-697752:Master case
"Moderna  Covid 19 vaccine Eua" Swelling in feet and legs. Turned serious very quickly went to ER skin was so tight that cracking occurred with sores. Intravenous  antibiotic and oral antibiotics given for treatment
Patient received a Pfizer BioNTech Adolescent/Adult Vaccine (Lot# 301458A) that was stored in the regular freezer (-25 to  -15 oC) beyond 14 days. On 22JAN22 Pfizer responded to the Health Agency that stability data does not support the use of the Pfizer Vaccine (Lot# 301458A). Pfizer further states decision to release or dispose of the product is the responsibility of local authority. The CDC website states that if the manufacturer does not have the information to support the stability of the vaccine, repeat the dose immediately with no minimum interval.
pt recvd vax & had inc fever; chills; shakey; episodes of cyanotic & hands; pale face; t 104.5;
Vaccine administered at 10:45 AM; patient noticed rash, swelling, soreness, bruising and lump at injection site late that evening. Sought treatment via MD at clinic on 11/16/2014--above symptoms present, slight fever, other vitals normal.  Treatment was with oral cephalexin.  Patient reported improvement by evening 11/16/2014 after only 2 doses of cephalexin.
Mother reports fever of 103 x 2days, not relieved by Tylenol and Ibuprofen. Pt was fussy, also. Mother called pediatrician who was not concerned, but mother feels this behavior is not normal for this child. Child also has twin brother who has received the same vaccines and tolerated them. Referred to pediatrician for recommendation for future immunizations.
Patient developed red "Rash" according to mother on top of both legs on 4/13/2009 and was taken to doctor on 4/16/2009
Case number PHEH2014US024445, is an initial spontaneous report received from a pharmacist on 04 DEC 2014. This report refers to a female patient of unknown age. She was vaccinated with FLUVIRIN 2014/2015 (batch number: unknown) intramuscular on an unknown date. On an unspecified date post vaccination she experienced hyperpigmentation at the site of injection. Pharmacist reported that she was taking a lot of dermatological medications (unspecified). Outcome of the event was unknown. Seriousness and causality assessment was not reported.
pain in her right leg; sadness; feels like her body is burning; dizziness; not feeling good; shingles on the left side of her mouth; couldn't open her mouth; depression; burning gums; stomach issues; can't sleep; can't go to the bathroom; only wanting to sleep; vomiting; nausea/nauseas so strong she couldn't eat; fever that wouldn't leave; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (right leg), DEPRESSED MOOD, BURNING SENSATION, DIZZINESS, and FEELING ABNORMAL in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012f21a and 063e21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CARVEDILOL, VITAMIN D, VITAMIN C, and VITAMIN E for an unknown indication.   On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Oct-2021, 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 PAIN IN EXTREMITY (right leg), DEPRESSED MOOD, BURNING SENSATION, DIZZINESS, FEELING ABNORMAL, HERPES ZOSTER, DYSKINESIA, DEPRESSION, GINGIVAL DISCOMFORT, ABDOMINAL DISCOMFORT, INSOMNIA, MOBILITY DECREASED, SOMNOLENCE, VOMITING, NAUSEA, and PYREXIA. The patient was treated with TYLENOL for Adverse event, at an unspecified dose and frequency and ACETAMINOPHEN for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (right leg), DEPRESSED MOOD, BURNING SENSATION, DIZZINESS, FEELING ABNORMAL, HERPES ZOSTER, DYSKINESIA, DEPRESSION, GINGIVAL DISCOMFORT, ABDOMINAL DISCOMFORT, INSOMNIA, MOBILITY DECREASED, SOMNOLENCE, VOMITING, NAUSEA, and PYREXIA outcome was unknown.            Patient reported treatment medication as antibiotics, ice pack, and tea  Patient reported use of concomitant medication high blood pressure medicine.
Large raised (red/warm to touch/itchy) lump that also had a rash at injection site that got bigger on 4/2/21 after 2nd shot. Lump dissipated but itchy rash continues and now covers almost half of arm above elbow 4/6/21. No trouble breathing.
Patient complained of a very severe headache, worse than her migraines.  Duration of 4 hours.
Erythema, slight tenderness @ injection site 1 day after immunization; OTC Ibuprofen for pain and edema; warm compresses.
Incoming TC from patient, reporting possible COVID-19 side effects / adverse reaction: Pt reported Friday 6/4 after 2nd dose Pfizer, felt chest pain and trouble breathing, stayed 20mins for observation at vaccine site, then pulled over on her way home. States she felt better after 10mins and drove home. Did not seek emergency care. Reports earlier 6/7/21 had episodes of same symptoms. Reports difficulty breathing, dizziness, and abdominal cramping. Advised to seek emergency care or call 911. Pt agreed, has family to drive her to ED.
Mom reports onset of a rash around the injection site on left leg. Area is firm under skin with small, raised pustules.
Erythematous round warm area on left upper arm- marked area with permanent marker and advised pt to take Benadryl and put ice on the area and if it increased in size to call the clinic.
Storage of vaccine was in refrigerator instead of the recommended location of the freezer and therefore out of temperature range 11/30/2022 and vaccine given 12/21/2022. Vaccine given intermuscular instead of subcutaneous.
Systemic: neck stiffness-Medium, Additional Details: Around 5:30 PM PST, I received  a call from a  call center, requesting to talk with the provider. I spoke with the patient and the patient's mother. Patient stated that she developed neck stiffness at night after receiving menactra. The symptom is gradually worse in the morning. Denies rash, shortness of breath or tingling. Pt stated that she feels like having a "bulging" behind her neck. Advised to see return to the clinic today or visit near by urgent care to be further evaluated
Information was received on 28-APR-2017 from a nurse practitioner via a company representative regarding the nurse practitioner's daughter. Medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date (reported as when the patient was 11 or 12 years old- she is now 22 years old) the patient received a dose of "GARDASIL 4" (dose not reported) for the indication of HPV prevention. It is unknown if the patient received the full series of "GARDASIL 4". Just recently, on an unspecified date, the patient developed an "abnormal pap." The reporter was unsure if any other lab work with done. The patient sought medical attention- she went to an unspecified healthcare professional. No further information was provided. Action taken with "GARDASIL 4" was not applicable. The outcome of abnormal pap was not reported and the causality was not reported. Additional information has been requested.
Breast cancer; A spontaneous report was received on 05 Feb 2021 from a consumer concerning an unknown age, female patient who received Moderna's COVID-19 vaccine and diagnosed with breast cancer.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 20 Jan 2021, patient received their first of two planned doses of mRNA-1273(Lot number: unknown), for the prophylaxis of COVID-19 infection.  On 03 Feb 2021, the patient was diagnosed with breast cancer.     Action taken the second dose of mRNA-1273 in response to the events was not reported.  The outcome of the event, breast cancer was not resolved.  The assessment of the causality by reporter was, there was no relation between the vaccine and the diagnosis of cancer, but as the event occurred after the administration of the Moderna COVID-19 vaccine.; Reporter's Comments: Based on the current available information, the event was diagnosed 15 days after the administration of mRNA-1273.  Due to the nature of development of breast cancer, the event was assessed as unlikely related.  Further information has been requested.
Blueish purple injection site; Red injection site; Hot injection site; Chest tightness; Could not talk very well; Itching injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Hot injection site), INJECTION SITE DISCOLOURATION (Blueish purple injection site), CHEST DISCOMFORT (Chest tightness), SPEECH SOUND DISORDER (Could not talk very well) and INJECTION SITE PRURITUS (Itching injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 03-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 INJECTION SITE ERYTHEMA (Red injection site). On 16-Feb-2021, the patient experienced INJECTION SITE DISCOLOURATION (Blueish purple injection site). On an unknown date, the patient experienced INJECTION SITE WARMTH (Hot injection site), CHEST DISCOMFORT (Chest tightness), SPEECH SOUND DISORDER (Could not talk very well) and INJECTION SITE PRURITUS (Itching injection site). At the time of the report, INJECTION SITE WARMTH (Hot injection site), INJECTION SITE DISCOLOURATION (Blueish purple injection site), CHEST DISCOMFORT (Chest tightness), SPEECH SOUND DISORDER (Could not talk very well), INJECTION SITE PRURITUS (Itching injection site) and INJECTION SITE ERYTHEMA (Red injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Red, swollen area to left upper arm area size of woman's open hand. Per patient area also itches. Advised patient to take, pain fever reliever and antihistamine for itching use cold or warm compresses as needed. Follow up with PVT MD or ER if symptoms continue.
Administration error, patient receives 1st dose for Pfizer and second dose for Moderna. Patient doesn't present allergic symptoms o any adverse reaction.
Initial unsolicited report received from a pharmacist and additional information received from a consumer (patient himself) on 11-Sep-2017. This case involves a 66-year-old male patient who was vaccinated with first intramuscular dose of FLUZONE HD (batch number: UI832AC, expiration date: 20-Mar-2018, dose was not reported) in the right deltoid on 27-Aug-2017. Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported that the patient had nasal Allergies and history of back and neck pain but the patient did not have any illness at the time of vaccination. Concomitant medications were not reported. On 27-Aug-2017 in the night, same day following the vaccination, the patient had severe pain in his right deltoid area and sharp pain with range of motion, he has no redness heat or swelling at the injection site. He said for a few days it improved but, never went completely away and he was still working while he had the pain and he was out of town right now. It really hurts when he moved it a certain way and planned to see his doctor as soon as he returns. It was also reported that he let the pharmacy (where he was vaccinated) know he had the severe pain, the next day they told him that they had reports of that, so he was not worried, they advised that he see his doctor as soon as he could (required emergency room (ER)/ doctor visit). Laboratory investigations were reported as none. Corrective treatment was not reported. The outcome of the events was reported as not recovered (reported that today during a break, the patient called the pharmacy to let them know his arm was not better). List of documents held by sender: none.
5 inch raised, hard, warm and itchy area on injection site. Patient does not complain of any systemic effects. Patient has self treated with hydrocortisone cream and Coridicin HBP Cough and Cold for its allergy component. The raised area was 3 inches and now a day later it is approximately 5 inches.
Developed erythema and induration at site 24hr later. Treated with ice, Motrin and Benadryl.