chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Long term tiredness lasting over 2 weeks since first vaccine.   Second vaccine scheduled next week on 04/08/2021
Mother of baby came into WIC department today and stated her baby got shots and the next day her baby died. 9/19/06 Received ER medical records which reveal patient was sleeping on couch overnight & was found unresponsive next am with bloody sputum around nares.  Arrived to ER in full arrest & resuscitation was unsuccessful.  9/19/06 Received autopsy report which reveals COD as SIDS/ss
Vaccine is placed in refrigerator on 22-Oct-2021, expired product date on 03-Oct-2021, administration date on 29-Nov-2021.; doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine is placed in refrigerator on 22-Oct-2021, expired product date on 03-Oct-2021, administration date on 29-Nov-2021.) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine is placed in refrigerator on 22-Oct-2021, expired product date on 03-Oct-2021, administration date on 29-Nov-2021.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine is placed in refrigerator on 22-Oct-2021, expired product date on 03-Oct-2021, administration date on 29-Nov-2021.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter. There was a confusion between the expiration date printed in the carton and the expiration date when the QR code was scanned. Date place in refrigerator was 22Sep2021. Patient did not experience temperature excursion and any adverse event   No treatment medication was provided by reporter.
Lose 12 pounds  (From 162 lbs to 148 lbs); Weakness in her left arm and hand; Tremor; This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT DECREASED (Lose 12 pounds  (From 162 lbs to 148 lbs)), ASTHENIA (Weakness in her left arm and hand) and TREMOR (Tremor) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21A and O26A21A) for COVID-19 vaccination.     Concurrent medical conditions included Grass allergy. Concomitant products included ATENOLOL, CHLORTALIDONE (ATENOLOL CHLORTHALIDONE) for Blood pressure, PRAVASTATIN for Cholesterol, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder NOS.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Nov-2021, the patient experienced ASTHENIA (Weakness in her left arm and hand) and TREMOR (Tremor). In January 2022, the patient experienced WEIGHT DECREASED (Lose 12 pounds  (From 162 lbs to 148 lbs)). At the time of the report, WEIGHT DECREASED (Lose 12 pounds  (From 162 lbs to 148 lbs)) outcome was unknown and ASTHENIA (Weakness in her left arm and hand) and TREMOR (Tremor) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Colonoscopy: normal (normal) normal. On an unknown date, Computerised tomogram: normal (normal) normal. On an unknown date, Magnetic resonance imaging: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment details were reported. Patient mentioned that from 162 pounds she was now at 148 pounds. Patient states she prefers to be contacted through phone.
A report was received from a health care professional on 11/24/03 concerning a 64 year old male vaccinee who was inadvertently administered frozen Fluvirin vaccine on an unreported date. On an unknown date, the vaccinee inadvertently received Fluvirin, which had been left adjacent to a freezer compartment and was subsequently frozen. The vaccinee will be advised to receive Fluvirin again in 3 weeks time. It was not reported if the vaccinee had experienced any adverse reaction. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
The patient fainted after receiving the vaccine. It was app. 5 minutes after receiving the vaccine that the patient fell over from his chair in our waiting area. The pharmacist helped him back up and the patient stated he was just nervous/anxious. He was given water and started to feel better. After an additional 15 minute the patient left. No medications were given.
Patient called today and said she had several episodes of "dizziness" since getting the flushot on 9-19-19.
dizziness immediately after injection, lasted 2-5 minutes, patient stayed in room for an additional 15 minutes for observation and was released.
L deltoid injection was painless. Extreme swelling and pain of entire deltoid followed. Next day swelling ruptured resulting in swollen inflamed biceps area. Was scheduled for surgery on day 3 so saw orthopedic surgeon on day 2 who told me that I had a severe reaction and to never again get that vaccine. (PPSV23). Surgery was on opposite arm successful following day after taking antibiotics for possible cellulitis.
Slightly more tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 79-year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 17Feb2021 13:30 (Lot number: EM9810) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Heart murmur", start date: 1999 (ongoing); "Hypertension", start date: 1999 (ongoing); "High Cholesterol", start date: 1999 (ongoing); "Arthritis knee" (ongoing), notes: Replacements in 2012, 2013; "Diabetes Type 2", start date: 2000 (ongoing); "Kidney stones", start date: 2000 (ongoing), notes: lithotripsy in 2006, 2010, 2011; "IBS", start date: 2000 (ongoing). Concomitant medication(s) included: ATACAND COMB taken for hypertension, start date: 2001 (ongoing); LIPITOR [ATORVASTATIN] taken for blood cholesterol increased, start date: 1999 (ongoing); METFORMIN taken for type 2 diabetes mellitus, start date: 2002 (ongoing); ALLOPURINOL taken for nephrolithiasis, start date: 1980 (ongoing). Past drug history included: Glipizide, start date: 2018, reaction(s): "Bruising"; Glipizide, reaction(s): "Bleeding". Vaccination history included: Bnt162b2 (1st Dose), administration date: 27Jan2021, for COVID-19 Immunisation, reaction(s): "tenderness arm". The following information was reported: FATIGUE (non-serious) with onset 17Feb2021, outcome "unknown", described as "Slightly more tired". Therapeutic measures were taken as a result of fatigue (extra fluid). No follow-up attempts are possible. No further information is expected.
103.1 F temperature within 90 minutes following administration of vaccine lasting approximately 8-9 hrs. Spontaneous recovery with no known sequelae. Gave Tylenol to bring fever down.
Pt admitted on 8/3/2021 with increasing sob. Pt notes he is fully vaccinated with Pfizer, last dose in March. Increase sob began about 2 weeks ago. Tested positive for COVID - sent to infusion clinic for Regeneron. Comes to ED with tachypnia, cough, myalgias. Sats 58 on room air.  Pt is currently inpatient at this time.
Patient fainted as he was walking out of our counseling room door. I was right behind patient as he was headed out the door. Therefore, I was able to catch him before dropping to the floor as he fainted. He never hit his head. I laid him on the floor and then I called for one of my technicians to come help me. Patient quickly came to after I had laid him down. He asked what happened and I told him he fainted on his way out the door. He said did not realize it happened and said he thought he was in a "dream". My technician then came into the counseling room. She got patient cool rags for on his forehead and the back of his neck. She also got him some of our unused lab coats for his head to rest on along with a bottle of water to drink. Patient was laying on our counseling room floor for about 20min from 5pm to 5:20pm. During the first part of the twenty minutes, patient's coloring was pale, bottom lip was shivering and he said his hands were tingly. RN then suggested that patient elevate his feet up on the chair. During the latter part of the the twenty minutes, he was feeling better (his color came back, no tingling and his bottom lip stopped quivering). Then he sat up leaning against a chair for about 5 minutes while still on the counseling room floor. Then he got up and sat in the chair for another 5-10 minutes. While in the chair, he talked about how he has fainted before while getting blood drawn. I stated that he marked no on our screening question #3. Question #3 reads, Have you ever had a serious reaction or fainted after receiving any vaccination or injectable medication. He stated he marked no that he has not fainted before because it was not after a vaccination or injectable medication like the question had asked, he fainted after having his blood drawn. I told him to make others aware he has fainted due to both factors now. Patient also talked about this being why he only wanted to get the Janssen vaccine because it was the one shot and he didn't want the chance of fainting twice. I then told him that a booster is recommended after getting the J&J and it should be either Pfizer or Moderna. After the 10min of sitting in the chair, he was feeling much better. So I told him that I would like for him to sit out in the waiting area for an additional 15 minutes to make sure he was okay and also so he could finish his bottle of water. He sat there with his friend talking and drinking the water. Then they left. ITEM 22- I HAVE NOT BEEN ABLE TO REACH PATIENT TO VERIFY THAT HIS ANSWER TO THIS QUESTION IS NONE.  BUT HE DID ANSWER NO TO OUR SCREENING QUESTION #7, HAVE YOU RECEIVED ANY VACCINATIONS IN THE PAST 4 WEEKS. ITEM 23- AS STATED ABOVE, HE HAS FAINTED DUE TO BLOOD DRAWN BUT NOT ANY PREVIOUS VACCINES.
This case was reported by a pharmacist via call center representative and described the occurrence of rash acneiform in a adult male patient who received SHINGRIX (batch number M77B4, expiry date 8th February 2021) for prophylaxis. Co-suspect products included ADACEL (batch number C5541AA, expiry date 13th November 2020) for prophylaxis. Previously administered products included Tdap vaccine (received on an unknown date and well tolerated). On 24th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml and ADACEL. In August 2018, 3 days after receiving SHINGRIX, the patient experienced rash acneiform, hives and itchy rash. The patient was treated with CLARITIN and BENADRYL. On an unknown date, the outcome of the rash acneiform, hives and itchy rash were not recovered/not resolved. It was unknown if the reporter considered the rash acneiform, hives and itchy rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional was not able to provide the patient's initials or birth date. The healthcare professional reported that the patient received both SHINGRIX and ADACEL in opposite deltoids. It was not known that which vaccine was given in which deltoid. Three days after administration of these 2 vaccines, the patient developed an itchy acne-like rash on his back and hives, which do not itch, on his chest. He consulted the pharmacy on 30th August 2018 and the pharmacist recommended BENADRYL or CLARITIN.
Soreness in left arm that won't go away. Reduced mobility...difficulty raising arm above shoulder or across the body. Sharp pain.
Started to lose hair after getting first dose of the vaccine.; Runny nose after getting the first dose of vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Started to lose hair after getting first dose of the vaccine.) and RHINORRHOEA (Runny nose after getting the first dose of vaccine.) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032H271A) for COVID-19 vaccination.     Patient was never diagnosed or tested positive for COVID-19. Patient does not have any acute illness at the time of vaccination or one month before.  The patient's past medical history included Carpal tunnel syndrome in January 2022, Dizziness (no recent changes) in 2017 and Surgery in January 2022. Concurrent medical conditions included Penicillin allergy (Patient was allergic since she was a kid.), Allergy to NSAIDs (Patient was allergic since she was a kid.), Heartbeats irregular (Since patient was a kid.), Allergy to NSAIDs (Ibuprofen), Cervical disc degeneration (no recent changes) since 2015, Cardiac murmur (no recent changes) since 2018, Vitamin D deficiency, Hypertension and Neck pain. Concomitant products included METOPROLOL for Hypertension, GABAPENTIN, OXYCODONE and TRAMADOL for Neck pain, VITAMIN D NOS for Vitamin D deficiency.    On 23-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Dec-2021, the patient experienced ALOPECIA (Started to lose hair after getting first dose of the vaccine.) and RHINORRHOEA (Runny nose after getting the first dose of vaccine.). On 23-Dec-2021, RHINORRHOEA (Runny nose after getting the first dose of vaccine.) had resolved. At the time of the report, ALOPECIA (Started to lose hair after getting first dose of the vaccine.) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, Blood test: normal (normal) Normal. In January 2022, SARS-CoV-2 test: negative (Negative) Negative. In January 2022, Urine analysis: normal (normal) Normal.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No vaccine received 1 month prior to Moderna Covid-19 Vaccine. Patient did not experienced similar events in the past. Patient mentioned that they do not have any family history of hair loss. No treatment information was provided.   This case was linked to MOD-2022-553114 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2022: Follow up received reporter added, medical history, concomitant medications and vaccine route of administration added. Indication of concomitant drugs also updated
Intractable headache started @ 7 hours after dose with subsequent nuchal rigidity and light sensitivity starting @ 13 hours after dose. Symptoms last 46 hours.
A pharmacist reported that a 25 year old female received an injection of Flu Shield (2001-2002 Formula) on 26 NOV 2001 and the next day, developed an injection site reaction characterized by redness, pain, and slight swelling. The patient recovered without treatment within 48 hours. The reporter indicated that this event was "possibly due to the reported absence of swabbing injection site" prior to vaccine administration. As of the date of this report, no further information was available. This is 1 of 3 patients from this facility to experience an adverse event following receipt of Flu Shield (2001-2002 Formula) lot 4018040. See MCNs: HQ9047003DEC2001 and HQ9041603DEC2001.
Patient received  high dose flu shot in pharmacy. Relative called 10 hours later, said pt had difficulty breathing, probably going to ER.
This office was informed 3-26-07 that patient "passed out" on Saturday 3-24-07 and was hospitalized at hospital (by patient's mother). Nurse at hospital subsequently called stating that patient had a reaction to DTaP. 4/24/07 Received medical records from hospital which reveal patient experienced fussiness, floppy, limp, difficult to arouse for approx 10 min.  EMS transported to ER & patient admitted overnight 3/25/07-3/26/07 for observation.  No further episodes occured & patient d/c to home in good condition.   FINAL DX: Hypotonic-hyporesponsive episode, probably secondary to vaccine.  Patient not to have pertussis again.
After vx, lymph nodes under arm became swollen. Was very large and sore for about a week or so, has remained a little swollen.
A report was received from a health care professional on 11/25/03 concerning a 2 year old male vaccinee who was inadvertently administered 0.5ml Fluvirin vaccine on 11/24/03. On 11/24/03 the vaccinee inadvertently received 0.5ml Fluvirin. At the time of the report the outcome was not reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Follow up letter returned unopened on 8/3/04. No new information provided.
full body fatigue; Experiencing arm soreness; 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 in left arm on an unspecified date on Mar2021 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient did not receive any other medication within 2 weeks of vaccination. Prior to vaccination the patient had been diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On an unspecified date on Mar2021, the patient experienced arm soreness and full body fatigue 24 hour after receiving first dose. No therapeutic measures were taken as a result of the events. 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 events arm soreness and full body fatigue were recovering at the time of report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report has been received from a male patient of unknown age, who was reporting on himself. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 01-SEP-2010, the patient was vaccinated with ZOSTAVAX injection (dose, route of administration, lot # and expiration date were not reported). On 06-SEP-2010 (reported as 5 days after receiving the vaccine), the patient developed neuropathy. The patient also reported he has been treated by four different neurologists who have not been able to help him. No product quality complaint was involved. Therapy with ZOSTAVAX was not reintroduced. The outcome of the event was not recovered. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
pt is the mom of 2 child who recv varicella vax;pt daughter devel diffuse rash which lasted 1 day;approx 7 days later pt devel chickenpox;
Fever of 101, malaise, bitter taste in mouth, pain on the injection site of the arm
This spontaneous report as received from a medical assistant refers a patient of unknown demographics. On an unknown date in August 2012, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported). The medical assistant reported that the vaccine was exposed to temperature of 26 F (Fahrenheit) for a total of 135 hours. No adverse effects reported. Follow-up received. Medical assistant stated that other 104 children received GARDASIL. Follow up information has been received from the medical assistant regarding a 14 years old, female patient with no pertinent medical history reported. On 16-NOV-2012 the patient was vaccinated with GARDASIL (lot number and expiration date not reported) (intramuscular on the left arm, dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. Additional information is not expected.
Fever of 100.2; loss of appetite x 2 days. vomit x 2; irritable on 22FEB-23FEB. Awake at night. Fever range 99.8-100.8 ax. Cried 22FEB more than usual approx 1 hr duration. Con't w/low grade temp.
Pain and swelling in.  arm Fever, low-grade Chills Achiness Fatigue Headache
Widespread vesicles. Dx: varicella. Tx: Acyclovir.
Information has been received from a physician concerning two patients in their 50 who on approximately 09-DEC-2008 ("last week") were vaccinated with a dose of PNEUMOVAX (663012/1163X). The physician reported that the two patients experienced a severe local reaction and a fever of 102 degrees within 24 hours of being vaccinated with PNEUMOVAX. The physician contacted the center and was told to discontinue using lot # 663012/1163X however a specific explanation for this was not available at the time of the call. The two patients sought unspecified medical attention. At the time of the report the two patients were recovered. Attempts are being made to obtain additional identifying information to distinguish the individual patients. Follow up information received from an office manager indicated that one patient was a 50 year old male. The patient received a dose of PNEUMOVAX (lot # 663012/1163X) on 10-DEC-2008. The patient was not hospitalized. Follow-up information from the office manager indicated that the 50 year old patient with no medical history or allergies received a dose of PNEUMOVAX IM, 0.5 mL (lot # 663012/1163X) on 10-DEC-2008. Concomitant therapy included "thyroid mediation" (manufacturer unspecified). Subsequently, the patient couldn't move his arm where he received his injection and experienced chills and fever. The patient saw the physician and a complete blood count was preformed (result unknown). The patient recovered on 15-DEC-2008. This is one of two reported from the same source. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center and was released. This is a consolidation of two reports concerning the same patient. Additional information has been requested. It has been determined that WAES # 0812USA04572 is a duplicate of WAES # 0812USA04696. Therefore, WAES # 0812USA04572 is being deleted from our files and the reports consolidated into 0812USA04696.
On January 22 at approximately 2:00am I woke up with severe body aches and nausea where I vomited at that point. As the morning progresses my body aches got much worse in addition to having a severe headache. I continued to vomit through out the day and was barely able to stand or walk, along with being very fatigued. These symptoms continued through out the entire day and did not subside until late the next morning.
Headache, Fever, Extreme Fatigue, Low Back Pain Narrative:  EMPLOYEE CALLED CLINIC THIS MORNING TO REPORT REACTION TO RECEIVING HER 2ND PFIZER COVID VACCINATION ON 2/3/21 @ APPROX 3:15PM. EMPLOYEE STATES SHE FELT FINE THE DAY OF BUT THE FOLLOWING DAY 2/4/21 SHE FELT A LITTLE FATIGUE THAN USUAL AND THOUGH MAYBE IT WAS THE WEATHER. EMPLOYEE STATES SHE WOKE UP THIS MORNING 2/5/21 WITH A LOW GRADE FEVER, H.A., LOWER BACK PAIN AND EXTREME FATIGUE. EMPLOYEE STATES SHE HAS CALLED IN FOR THE DAY AND INSIST SHE NEEDS TO RETURN TO HER BED.
Chills, headache, metal taste and cotton mouth, aches and cramps in back and abdominal area. Swollen lymph nodes in right arm pit into right upper chest. Tight chest. Red rash on right arm about two inches from injection site.