chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; adult patient received Moderna Covid-19 vaccine past it's 30 day use by date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (adult patient received Moderna Covid-19 vaccine past it's 30 day use by date.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Oct-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (adult patient received Moderna Covid-19 vaccine past it's 30 day use by date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (adult patient received Moderna Covid-19 vaccine past it's 30 day use by date.) 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 (adult patient received Moderna Covid-19 vaccine past it's 30 day use by date.).    No concomitant medication information provided.  Individual vials or unbroken cartons: 1 individual vial.   Vial size was 5.5ml  Date the vial was initially stored in the refrigerator was unknown.  The vial did not undergone any temperature excursions.  No treatment information provided.
Increase hair growth since 2nd dose vaccination requiring weekly hair cut.; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 49 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 18Mar2021 (Lot number: ENG207) at the age of 49 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Psoriatic arthritis" (unspecified if ongoing); "Allergies: Sulfa drug" (unspecified if ongoing); "Allergies: penicillin" (unspecified if ongoing). Concomitant medication included: OTEZLA. Past drug history included: Aspirin, reaction: "Allergies: Aspirin"; Tylenol, start date: Feb2021, for Painful headache behind left eye; Ibuprofen, start date: Feb2021, for Painful headache behind left eye. Vaccination history included: BNT162B2 (Dose 1, arm left; Lot number ENG202; Administration time 04:00 PM), administration date: 25Feb2021, when the patient was 48 years old, for COVID-19 immunization, reactions: "Painful headache behind left eye", "Extremely tired", "Slept for 23 hours straight afterwards". The following information was reported: HAIR GROWTH ABNORMAL (non-serious) with onset 2021, outcome "not recovered", described as "Increase hair growth since 2nd dose vaccination requiring weekly hair cut.". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since vaccination.  No follow-up attempts are needed. No further information is expected.
They scanned her thyroid came back high; Severe anterior neck pain for so many weeks; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 40 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Subacute thyroiditis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1, Manufacturer unknown), for COVID-19 immunization. The following information was reported: HYPERTHYROIDISM (medically significant), outcome "unknown", described as "They scanned her thyroid came back high"; NECK PAIN (non-serious), outcome "unknown", described as "Severe anterior neck pain for so many weeks". The patient underwent the following laboratory tests and procedures: thyroid function test: high, notes: that's where her lymph nodes are. Therapeutic measures were taken as a result of neck pain. 4 days after second dose the patient experienced severe anterior neck pain for so many weeks treated with Prednisolone, they scanned her thyroid came back high, that's where her lymph nodes were.   The lot number for bnt162b2 was not provided and will be requested during follow up.
I got my vaccine, after my second dose I've noticed something likes blisters in my face neck head and ears and it's itchy but I put cortisone ointment petroleum jelly and take allergy medicine bynadrl ,when i got my booster 10/28/2021 I felt more itchy entire of my body and getting more worse I felt I was rotten, I went to my work place clinic 02/13/2022  they told me to see a doctor right away because my body was 64% infected of severe rashes they send me home, now I under medication of a doctor dermatologist, she under go biopsy/my blood laboratory/ medication dapsone/prednisone and five kinds of ointments until I am under medication and has always continued.
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patient's concurrent conditions, concomitant medication and medical history were not provided. Since 04-NOV-2015, on unspecified dates, the patients were vaccinated with unspecified doses of improperly stored GARDASIL 9 (lot # K026246, expiry date 28-JAN-2017) (strength, dose and route were unspecified). No adverse effects had been reported. This is one of several reports received from the same source. Additional information has been requested.
After my 1st dose of the Moderna vaccine my arm was tender the following 3 days. That went away. Then 7 days out from the 1st dose my arm became tender again and I noticed a red rash around the injection site, about 2" in diameter. It was  more inflamed on day 8. We are now on day 9 and the redness has lessened, however it is still tender. There is no itching and it does not appear to be infected. I inquired about this reaction with the pharmacist who administered the vaccine and he advised me to report it to the CDC.
Rec'd Dtap #5 10/26/04 woke up 10/28/04 with red and swollen arm. Area 15cmx14cm warm, red, swollen, Tx with Benadryl.
A non-serious report of administration of expired product was received from a registered nurse concerning a 38-month-old female. Neither medical history nor concomitant medications were reported. On 29-Dec-2008, two siblings, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of 23-Dec-2008. There was no adverse event associated with medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with a post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Additional information was received on 10-Mar-2009 that no delayed adverse events resulted from this error. 3/25/2010 Based on the results of the investigation, the root cause fro the medication errors were caused by 1) customers not discarding product from the previous season and  2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Additional information received on 09-Apr-2009 product complaint investigation results.
Exam of the right shoulder. Shows area of erythema upper lateral shoulder which is warm to touch shoulder motion is markedly limited to 50 degrees abduction secondary to pain. Neurovascular is intact distally. Adverse reaction to vaccine. Given 125 g methyl prednisone IM.
Pt recvd 3 doses Engerix-B 19JUN90, 17JUL90 & 11DEC90 & failed to convert to protected levels;
Sour taste in mouth; This is a spontaneous report from a non-contactable consumer, the patient. A 30-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on the right arm on 28Feb2021 at 14:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included gastrointestinal issues (GI) and irritable bowel syndrome (IBS). The patient had no known allergies to medications, food or other products. 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 magnesium (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. On 01Mar2021, the patient experienced sour taste in mouth. The event 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 event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event sour taste in mouth was not recovered at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Left arm started itching and a welt mark appeared. It was slightly red and about the size of a baseball. Has continued to spread is now within 3 inches of my elbow (Sat March 3) not itching as much and isn?t painful. At the start it was really hard and hot but seems to be getting better
Information has been received from a physician concerning a female approximately 14 or 15 years old with a history of seizures who on an unknown date was vaccinated with a first dose of Gardasil. Subsequently on an unknown date the patient fainted and when she came to she convulsed for about five seconds. The patient did not require any additional emergency intervention. Subsequently, on an unknown date the patient fully recovered. Upon internal review the event of convulsions was considered to be an other important medical event. Additional information has been requested.
Headache, Fever LOSS OF APPETITE, CHILLS, FATIGUE, MUSCLE ACHES Narrative:  SX APPEARED WITHIN 18-24 HOURS: SORENESS AND A HARD RED LUMP AT INJECTION SITE MUSCLE ACHES FATIGUE CHILLS TEMP OF 100.2 HEADACHE LACK OF APPETITE AND NAUSEA SX SUBSIDED BY 2/6/21 ON 2/8/21 DEVELOPED 2 FEVER BLISTERS ON THE LIPS  Other Relevant History:
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. From 19-APR-2017 to 23-MAY-2017, the patients were vaccinated with improperly stored doses of PROQUAD lot # M036295 with expiration date: 12-DEC-2018, lot# M041084 with expiration date: 04-APR-2018, lot# M044022 with expiration date: 01-MAY-2018 and lot# M042501 with expiration date: 17-APR-2018 (dose, route and site of administration were not reported). The sterile diluent (manufacturer unknown) was used to reconstitute the PROQUAD. The sterile diluent (manufacturer unknown) did not undergo a temperature excursion. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 32 degrees Fahrenheit to 35 degrees Fahrenheit for 24 hours. Data logger was not involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA014497: US-009507513-1705USA014496: US-009507513-1705USA014495: US-009507513-1705USA014494.
Received Shingrix vaccine on 5/10 at 10 am. Experienced fever, shivering, headache, nausea, pounding heartbeat, dizziness, fatigue, loss of appetite, cold hands and feet. Nauseastartedabout six hours after receiving, the rest of the symptoms followed two to three hours later and lasted for much of the night. No appetite, fatigue and brain fog the next day. Appetite not fully restored until three days after vaccine. Fatigue and weakness in legs upon exertion throughout the week. On 5/14/2021 woke up with dizziness, room spinning,balance off, nausea, vomiting, brain fog, head and neck pain, difficulty swallowing. Improved after vomiting. Treated with Bryonia, 30c by Dr. Continued to improve throughout
On Tuesday, December 6, 2022, my symptoms began as I woke up with a runny nose and a bit of a cough that was starting. I took a COVID-19 test and it was positive. I had a low-grade fever on and off. It would go up and down. As of today, I have not had a fever at all. I had chills occasionally. My appetite decreased. I had a telehealth visit with my doctor. I started PAXLOVID on Wednesday and have a few more days left. I am feeling much better today. I have had a productive cough and a runny nose.
A nurse reported that pt received vaccine, the next day he developed a reaction, which the reporter did not describe. He recovered.
Client came to Health Agency on 1/21/10. Reports had PNEUMOVAX in R arm and H1N1 shot in L arm on 1/20/10. Reports extreme pain in R arm post injection. R bicep area contains 3" x 7" red indurated area. Area warm to touch. Reports redness began 1/20/10 and became worse 1/21/10-seen at clinic on 1/22/10. MD stated was vaccine-related reaction. MD advised to apply heat to area.
Had PNEUMOVAX L arm 1/25. Now with swelling and pain above and below elbow. Has had prior PNEUMOVAX w/o SE. No SOB. Painful, not itchy. Plan: Doxy, prednisone, ZANTAC, BENADRYL. Rest, sling, elevate. Myalgia and Swelling around injection site. Diphenhydramine 25 mg once, methylprednisone 125 mg once, famotidine 20 mg once.
8 days after vaccine. Rash, erythema and localized raised reaction to left deltoid extending inferiority to mid arm. Itching, swelling as well
Red rash from shoulder to near elbow on left arm. Warm to touch and slightly raised. Slightly itchy. Noticed it on 01/24/2021 and marked it's size. It has grown about 1 inch outside of the marked location in the past 18 hours.
Neurological- dizziness, nausea, internal tremors (9/21/21- present day) Body inflammation- Joint pain, Stiff neck, Swollen lymph nodes (neck and armpits), arthritis  (9/21/21- present day) Mental health- Anxiety, Depression, brain fog  (9/21/21- present day)
Bexsero after Trumemba dose; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 16-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA68AA, expiry date 30th October 2021) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis and MENINGOCOCCAL B VACCINE (TRUMENBA) for prophylaxis.   On 31st March 2020, the patient received Bexsero, Bexsero Pre-Filled Syringe Device and TRUMENBA. On 31st March 2020, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced overdose. On an unknown date, the outcome of the overdose 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 provided as follows: The medical assistant reported that, the patient received a dose of Trumemba followed by a dose of Bexsero, which led to overdose. The reporter consented to follow up. No product details on Trumemba dose. The case has been linked with the case US2020238766 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020238766:Same reporter
Approximately 5 minutes post vaccination at the county public health center drive through vaccine clinic while patient was in the observation parking area the patient beeped her horn and indicated to staff she did not feel well. She had flushing of skin of the chest, and a cough that was just starting. EMS was called at 12:07 PM, and per standing order RN administered 50 mg of Benadryl intramuscularly in the right deltoid at 12:08 PM. The patient progressed to persistent coughing, wheezing, and difficulty talking stating she felt like a lump in her throat and tightening in her throat. Again, following standing order RN administered 0.3 mg of Epinephrine in the left thigh intramuscularly at 12:14 PM. EMS arrived by ambulance at 12:17 PM. Patient was stable upon EMS arrival with all signs/symptoms of allergic anaphylactic reaction gone.  EMS evaluated patient and patient signed declination to go to the hospital for evaluation. She remained on site until 12:41 PM when her father / mother came to pick her up from the vaccine clinic site. Follow up was done with patient on 04-21-2021 @ 11:30 AM. She states that no further reaction occurred, and she took no further medications.
Muscle cramps, stiffness, and pains, extreme tiredness 3 days couldn't get out of bed nor sleep 3 weeks later, chest pains, burning in chest, hot/cold streaks, arm pains, muscle weakness in arms, still unable to work at full capacity, extreme tiredness No
Pediatric vaccine was diluted with 0.13 ml instead of 1.3 ml so the patient got a more concentrated dosage than recommended. Patient presented pain at site of injection.
Immun given @230PM APAP given by mom p/got home; Pt slept till 430PM; Woke up cranky & fussy had 3 sz taken to ER; t104.7 in ER; Given Souprofin;
A non-serious spontaneous report was received on 27JUN2016 from a consumer. On 22JUN2016, the consumer received her 12th dose of BioThrax (anthrax vaccine adsorbed). On 25JUN2016 she experienced flu-like symptoms.  On 27JUN2016, she reported experiencing fever of 102.6 F (also reported as 104 F), abdominal pain, dizziness, nausea, weakness, fatigue, and sweating. Patient went to Urgent Care and was referred to emergency room where she had blood test drawn (test names and results unknown). No other treatment given in ER, no diagnosis given. The patient left emergency room due to the long wait of 5 to 8 hours to see a doctor. The subject self-treated symptoms at home with rest, fluids, and ibuprofen. On 28JUN2016, she reported that her fever began to break and that she had vomited. She also reported that she would not be going to work for the day. On 29JUN2016 she reported that her adverse events were resolving. Additional follow-up information was received on 04JUL2016 from a consumer's roommate that contained serious criteria that upgraded case to expedited. On 03JUL2016, per report by consumer's roommate, the consumer made two trips to a local emergency room both for a migraine. It was reported that the second visit resulted in an overnight stay at the hospital for more testing. The consumer's roommate reported that the consumer's liver was not functioning as it should. The consumer was reported to have slept for about a week except for the times that she was able to make it to work. Treatments reported include Ibuprofen, fluids and rest. No medical history reported. No concomitant medication reported. Relevant laboratory tests: Alanine aminotransferase - 260; Aspartate aminotransferase - 132; Blood alkaline phosphatase - 286; Glucose - 117; Neutrophil count - 8.03; White blood cell count - 11.33; Hepatitis panel drawn - waiting results. Additional information requested.
Headache Chills, Arm soreness up under arm pit. Narrative:  Other Relevant History:
Information has been received from a registered nurse concerning her husband a 62 year old male consumer with a history of penicillin allergy and no pertinent medical history who on 26-JUL-2007 was vaccinated subcutaneously with an "appropriate dose" of Zostavax (Oka/Merck).  Concomitant therapy included tetanus toxoid, LOTENSIN and LIPITOR.  On 11-AUG-2007 or 12-AUG-2007 the patient developed a widespread rash on his upper thighs, forearms, knees, and lower legs.  The rash is described as a papular-like rash, itchy, but not painful.  She does not feel that her husband has developed shingles, but possibly chicken pox.  The rash was no longer spreading.  At the time of this report the patient had not yet seen his physician, but it was reported that medical attention was sought.  No lab studies were performed.  No further information was provided.  There was no product quality complaint involved.  Additional information has been requested.
headache; injection site itching/started itching; injection site swelling/again was swollen; injection site redness/again was red; injection site heat/again was hot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (injection site itching/started itching), VACCINATION SITE SWELLING (injection site swelling/again was swollen), VACCINATION SITE ERYTHEMA (injection site redness/again was red), VACCINATION SITE WARMTH (injection site heat/again was hot) and HEADACHE (headache) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (injection site itching/started itching), VACCINATION SITE SWELLING (injection site swelling/again was swollen), VACCINATION SITE ERYTHEMA (injection site redness/again was red) and VACCINATION SITE WARMTH (injection site heat/again was hot). On an unknown date, the patient experienced HEADACHE (headache). At the time of the report, VACCINATION SITE PRURITUS (injection site itching/started itching), VACCINATION SITE SWELLING (injection site swelling/again was swollen), VACCINATION SITE ERYTHEMA (injection site redness/again was red), VACCINATION SITE WARMTH (injection site heat/again was hot) and HEADACHE (headache) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant information provided. Treatment included cortisone cream and cold washrag.   This case was linked to US-MODERNATX, INC.-MOD-2021-083158 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Follow up received on 07-JUN-2021 included updated AE information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-083158:dose 1
rinjection site redness/ Redness has started to move down to her elbow area; warmth (hot to touch); severe itching around the injection site.; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (rinjection site redness/ Redness has started to move down to her elbow area), INJECTION SITE WARMTH (warmth (hot to touch)) and INJECTION SITE PRURITUS (severe itching around the injection site.) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included AFib, Congestive heart failure and Cancer. Concomitant products included TAMOXIFEN and APIXABAN (ELIQUIS) for an unknown indication.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (rinjection site redness/ Redness has started to move down to her elbow area), INJECTION SITE WARMTH (warmth (hot to touch)) and INJECTION SITE PRURITUS (severe itching around the injection site.). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, INJECTION SITE ERYTHEMA (rinjection site redness/ Redness has started to move down to her elbow area), INJECTION SITE WARMTH (warmth (hot to touch)) and INJECTION SITE PRURITUS (severe itching around the injection site.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter did not allow further contact