chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial unsolicited report received from a non-healthcare professional on 05 November 2014. This case is a cluster of 2 cases and is linked to 2014SA155735 (Same reporter, vaccine and vaccine lot number). A 67-year-old female patient, whose concomitant medication was not reported, had received a dose of FLUZONE HD, (batch number, expiry date of vaccine, cycle in series and route of vaccination was not reported) in deltoid on 18-Oct-2014. On 18-Oct-2014, patient experienced chest congestion, sinus congestion, erythema at injection site and fatigue (patient was unable to go out of her house in over 1 week due to the extreme fatigue). Corrective treatment and lab investigations were not reported. Illness at the time of vaccination was not reported. Medical history was reported as; patient had allergies to numerous antibiotics, narcotics and aspirin. Corrective treatment and lab investigations were not reported. At the time of this report, the outcome of the event was reported as not recovered. Documents held by sender: none. Follow-up report received from a Consumer (the patient) on 29 January 2015. Lot number of vaccine was J5041BA and expiry date was 12 May 2015. The vaccine was administered intramuscularly in left arm.
Reports  x 1 week s/p vaccine on 2/20/2021. C/O sharp left sided chest pain, cough, wheezing and generalized weakness
May have received 1 or 2 doses prior; May have received 1 or 2 doses prior; This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent. On 28-OCT-2019, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (strength, dose, anatomical location, route was not reported) with a lot number S000618 has been verified to be a valid lot number for zoster vaccine live, expiration date not reported, but upon internal validation established as 06-APR-2020. The pharmacist reported that the patient "may have received 1 or 2 doses" of zoster vaccine live(ZOSTAVAX) prior to 28-OCT-2019 (extra dose administered and circumstance or information capable of leading to medication error). No product quality complaint was reported.
Headache, Vomitting 20-30 minutes from 8:00 AM until 1:00PM, dizziness, body chills until administered IV fluids and Zofran.
Patient  calls she received the covid  vaccine  01/07/2021    on 01/10/2021  she started experiencing numbness  from lip to lower chin   she is wondering if this would be a side effect of the vaccine reports she has had bells palsy in the past but it feels a little different . She has also had a headache since receiving the vaccine
Early and heavy period that started April 14th. Currently still bleeding as of May 3rd and no end in sight.
Dizziness, weakness, itching, head ache. no treatment. continues to have mild dizziness and headache (10-29-09)
When I returned home, approx. 30 mins after the vaccine was administered, I felt numbness in my face and the roof of my mouth. The best way to describe it is that my "face meat" felt numb.  So, not the surface skin, but deep down in the muscles. Almost like when you are numb from dental work.   I am still feeling the face numbness today. Not in the roof of my mouth so much, but in my face meat.
Had pain right away but not as severe as next day. Next day had severe pain on arm, not at vax site but directly on other side close to armpit. Had hot red spots in armpit no on. Went to doctor and was prescribed cephalexin (500 mg). Had improvement by 24 hours, on 3rd day still had pain during regular activities. By 5th day still had red mark by vaccine site but pain and everything else had subsided. Had received pneumonia vax before about 2-3 years ago had no problem.
Early on I went to Hosp for trying to find out what was wrong but was never diagnosed after about 3 months of time, early the next year I switched to another Hospital and a new doctor and in less than a month, the diagnosis of Rheumatoid Arthritis was made and I began treatment for that disease. It is difficult to be exact as the symptoms at became more intense with time until it was painful to walk at all.  The Rheumatoid Arthritis is in my feet and legs.  I had been a walker up until that time and walked about 3 miles a day and thoroughly enjoyed my walks. I had to give up my walks with that diagnosis. Clonidine HCL Amlodipine Besylate Bisoprolol Fumarate Latanoprost Levothyroxin synthroid First shot was at the filre station, the second was at a Church and I believe after that, the last two were at a School now owned by a College. A personal note.  I couldn't understand what would have triggered this reaction that caused my body to attack itself after being so healthy for so long.  It did not make sense and at first, I did not suspect the covid shots but more and more, after thinking about it. It was the only change that I had made in my health care over that particular time and it was not just one dose but 4 doses in a very short time.  The only other vaccination I had was the flue shot and I have never reacted to that in a negative way before.
A report was received from a healthcare professional on 22Nov02 concerning a group of vaccinees less than 4 year old of unk demography who inadvertently received Fluvirin from approx 07Nov02 onwards. From 07Nov02 Fluvirin was administered to vaccinees less than 4 years old. There were no reported adverse events. There was insufficient information to determine the reporter's causality assessment. Update 1 10Dec02: A follow up report was received from a health professional indicating that a 12 month old female vaccinee was inadvertently administered Fluvirin IM on 15Nov02. The vaccinee experienced no adverse reaction. Cross reference: PJP200200848, PJP200200849, PJP200200850, PJP200200851, PJP200200852, PJP200200853, PJP200200854, PJP200200855, PJP200200856, PJP200200857, PJP200200858, PJP200200859, PJP200200860, PJP200200861, PJP200200862, PJP200200805, PJP200200864, PJP200200866, PJP200200867, PJP200200868, PJP200200869, PJP200200805, PJP200200871, PJP200200872, PJP200200873, PJP200200874, PJP200200875, PJP200200876, PJP200200877.
UPPER ARM, BELOW SHOULDER, SWELLED WAY UP AND WAS VERY PAINFUL. THEN BY 10:00 PM IT STARTED SWELLING UP IN THE BICEP OF THE ARM ALSO AND WAS PAINFUL. THE NEXT MORNING IT IS STILL SWOLLEN AND A BIT PAINFUL YET IN BOTH AREAS OF THE ARM.
RASH, ERYTHEMA, URTICARIA/ITCH IN ARM, SHOULDER, HEAD AND NECK.
Chills; Severe headache; Vomiting; Diarrhea; Fatigue; Nausea; Malaise; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 30Sep2021 (Lot number: FF8839) at the age of 68 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6205, Location of injection: Arm , Route of administration: Intramuscular, Vaccine Administration Time: AM), administration date: 03Mar2021, when the patient was 67 years old, for COVID-19 immunization, reaction(s): "Headache", "Fatigue"; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6201, Route of administration: Intramuscular, Location of injection: Arm, Vaccine Administration Time: AM), administration date: 10Feb2021, when the patient was 67 years old, for COVID-19 immunization, reaction(s): "Headache", "Fatigue". The following information was reported: CHILLS (non-serious) with onset 30Sep2021 15:00, outcome "recovered with sequelae" (10Oct2021), described as "Chills"; HEADACHE (non-serious) with onset 30Sep2021 15:00, outcome "recovered" (10Oct2021), described as "Severe headache"; VOMITING (non-serious) with onset 30Sep2021 15:00, outcome "recovered" (10Oct2021), described as "Vomiting"; DIARRHOEA (non-serious) with onset 30Sep2021 15:00, outcome "recovered" (10Oct2021), described as "Diarrhea"; FATIGUE (non-serious) with onset 30Sep2021 15:00, outcome "recovered" (10Oct2021), described as "Fatigue"; NAUSEA (non-serious) with onset 2021, outcome "recovered" (2021), described as "Nausea"; MALAISE (non-serious) with onset 2021, outcome "recovered" (2021), described as "Malaise". Therapeutic measures were not taken as a result of chills, headache, vomiting, diarrhoea, fatigue.  Additional information: The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. The patient did not receive any other medications within 2 weeks. Prior to vaccination, the patient was not diagnosed with COVID. Since vaccination the patient was not tested for COVID. Booster headache fatigue nausea diarrhoea chills malaise lasted 9 days.  Follow-up attempts are completed. No further information is expected.
Pfizer-BioNTech COVID-19 Vaccine EUA:  injections site pain; tiredness; headache; muscle pain; chills; fever; nausea; feeling unwell began at 3am on 1/28/2021.  Giving Tylenol.
15 minutes, post vax, had swelling and pain in left hand and wrist. These symptoms gradually resolved but hand and wrist remained sore the next day. Pt seen on 10/24/00 and mild swelling on dorsum of hand observed. No swelling or erythema at injection site. This is the 2nd pt with such complaints after flu shot.
Circular 3.5" dark, itchy spot on arm.  Itching was extremely severe.  Area is still noticeable but light in color.  Wonder if my skin tissue has been affected?
This spontaneous report was received form a nurse refers to an unspecified number of unspecified patients. On unspecified dates in 2014 the patients were vaccinated with doses of RECOMBIVAX HB (lot #, expiration date, dose and route unspecified) which were exposed to a previous temperature excursion on 20-MAY-2014. The nurse was not aware of any adverse effects. This is one of several reports received from same source. Additional information has been requested.
pt recv 1st vax,exp arthritis,began as pain & stiffness in hands,wrists,neck & knees;arthralgia accompanied by weakness & malaise;recv 2nd dose,tests showed inc serum alk phosphatase,GGT<SGOT & SGPT;pos for anti HBc,hep A antibody;hepatitis
Patient fainted, body became rigid  and began seizing. Patient slid out of his chair and finally came to on the floor. 911 was called and EMS arrived and patient stabilized.
PT SHOWED UP TO SECOND DOSE APPOINTMENT AND OMITTED TO HAVING RECEIVED ANTIBODY INFUSIONS DURING HER HOSPITAL STAY ON SEPT 02, 2021 FOR SAR-COV2 .  SHE REPORTS TO HAVING HAD INJECTION SITE IRRITATION  FOLLOWING HER 1ST DOSE.  PHONE CALL WAS PLACED TO MODERNA  ON 11.24.21 FOR GUIDANCE ON ADMINISTERING 2ND DOSE.
ECCHYMOSES. DEVELOPED ITP WITH PLATELET COUNT OF 5 WHEN ADMITTED TO HOSPITAL. TREATED INPATIENT. SURVIVED.
HEART BEAT RAISING; Trembling; TINGLING IN HANDS AND FEET; SUPER COLD; Itching; CHILLS; TIREDNESS; FEVERISH; NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced heart beat raising. On MAR-2021, the subject experienced trembling. On MAR-2021, the subject experienced tingling in hands and feet. On MAR-2021, the subject experienced super cold. On MAR-2021, the subject experienced itching. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced tiredness. On MAR-2021, the subject experienced feverish. On MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from heart beat raising, tingling in hands and feet, super cold, and trembling, and the outcome of tiredness, chills, feverish, nausea and itching was not reported. This report was non-serious.; Sender's Comments: V.0 MAC not required per standard procedure as the case assessed as non-serious.
HORRIBLE HEADACHES; PAIN IN ARMS; NAUSEATED; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, ethnic origin, race and medical history were not reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry date: not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow-up to request batch number. No concomitant medications were reported. On an unspecified date, the subject experienced headache, pain in arms, and nausea. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, pain in arms and nausea was not reported. This report was non-serious.
Woke up with very red rash and hives all over body, difficulty breathing. Took 50mg BENADRYL. Gradually getting worse itching and shortness of breath. Was finally given epinephrine shot at 2am. Symptoms of rash disappeared immediately.
Pediatric dose was given to adults mistakenly; Poor quality product administered; Product temperature excursion; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered), PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered), PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered), PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered) and PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion).    No Concomitant medication was provided by reporter.   It was reported there was a temperature excursion between 26 May 2022 to 30 Sep 2022 and lot AR5186C was administrated between 08 Sep 2022 to 09 Sep 2022.AR5186C was previously reported. Pediatric dose was given to adults mistakenly and were reported to CDPH, VAERS, CAIR and each patient that received the error dose, with instructions to re-vaccinate 2 months from the initial error dose. 051B22A was kept in the freezer upon receipt of shipment on 08-Jan-2022 and individual vials were put in the refrigerator on the day of use.   No treatment information was provided.   This case contains information for the 14th of 104 patients described by the reporter.
Patient was accidentally administered the Pfizer BioNTech COVID-19 Vaccine Orange Top for 5 though 11 years of age instead of the Pfizer BioNTech COVID-19 Vaccine Gray Top  for 12 years and older.  No adverse reaction.
Hurt/ached from head to toes - even tips of fingers hurt. Very tired. Began feeling symptoms in eve of 9/24. Felt poorly 9/25 - went home early. Slept all day 9/25. Felt 100% better 9/26.
MMRV given off label for patient age 14 years. He should have been given MMR plus Varicella as separate doses. No reaction noted.
stress; not sleeping very well; sore arm; slight headache; This is a spontaneous report from a contactable consumer. This consumer reported similar events for three patients. This is the first of three reports. A 55-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231) via unspecified route of administration on 19Jan2021 at single dose in left arm for COVID-19 immunization. The patient's medical history included occupational exposure to COVID-19 (adult foster care, direct line caring for people). The patient's concomitant medications were reported as no. The patient experienced sore arm on 19Jan2021, slight headache on 19Jan2021. Sore arm went away between 20Jan2021 and 21Jan2021. She has recovered completely from sore arm. She is unsure if the headache was from the vaccine or stress, or several different things, such as not sleeping very well. Headache went away, she is not 100% positive, but maybe by the 22Jan2021, and she had recovered completely. The patient asked if she can take paracetamol (TYLENOL) or ibuprofen for side effects if have to. The outcome of sore arm and slight headache was resolved. The outcome of other events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021092693 same reporter/drug, different patient/ event;US-PFIZER INC-2021092694 same reporter/drug, different patient/ event
Received PNEUMOVAX 0.5 ml IM 6/5/09. Seen @ ER 5/7/09. DX: cellulitis (R) upper arm. Treated in hospital till 6/10/09. Discharge 6/10/09.  7/2/09 MR received for DOS 6/7-10/2009 with D/C DX:  Cellulitis of RUE, s/p Pneumovax injection.  Headache-resolved.  Pt presented with significant redness, swelling and tenderness at Pneumovax site as well as fever, weakness and fatigue. Admitted for IV abx after which pt developed a H/A and had improvement. D/C on oral abx.  ICD9 682.3
I have tried to right this down no 4 times and every time the document times out and makes me start over. At this point, call me, I would love to explain for an hour about everything I have been going through with significant chest pain since vaccination, and feeling of having mini heart attacks.  Started 14hours after vaccine with significant chest pain and squeezing, and has not gone away with constant daily chest pressure. Almost collapsed in a grocery store from what felt like a heart attack 12/15 which I ended up in the ER and was told to seek Cardiologist care.... CALL ME FOR MORE INFORMATION
Injection site swollen and warm but normal color and sore. Patient said that she ran a fever overnight.
TWO DAYS AFTER FIRST VACCINE - TONGUE TURNED BLACK. LASTED FOR OVER A WEEK 3 DAYS AFTER SECOND VACCINE - TONGUE TURNED BLACK. STILL HAVE SOMME BLACK SPOTS AS OF TODAY.
This spontaneous report as received from a other refers to unspecified number of patients of unknown age. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB for prophylaxis. No adverse event. Sender's Comments: US-009507513-1708USA013504:Original Case : 1708USA013476; US-009507513-1708USA013476:Original Case : 1708USA013476; US-009507513-1708USA013503:Original Case : 1708USA013476.
Arthritis, stomach pain, joint pain and cramps, itching, burning sensation, spots on skin, toe fungus, unbalanced, dizzy, erectile dysfunction, major depression, anxiety.
Swollen and tender axillary and pec lymph nodes; sore arm, R breast and R scapular area; sore arm, R breast and R scapular area; sore arm, R breast and R scapular area; R abdominal/flank pain; R abdominal/flank pain; mild fever; This is a spontaneous report from a contactable health professional, the patient. A 36-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular in the right arm on 20Jan2021 at 10:15 (at the age of 36-years-old) as a single dose for COVID-19 immunization. Medical history included hypertension and COVID-19 (diagnosed prior to vaccination), as of unknown dates. The patient had no known allergies. Concomitant medications included olmesartan, fish oil (OMEGA 3) and unspecified CLARITIN. The patient did not receive any other vaccines within 4 weeks of the vaccination. On 21Jan2021 at 16:00, the patient experienced swollen and tender axillary and pec lymph nodes, sore arm, right breast and right scapular area, right abdominal/flank pain and mild fever. The patient was treated for the events with acetaminophen (TYLENOL) and ibuprofen (ADVIL). Since the vaccination, the patient was tested for COVID-19 via nasal swab on 20Jan2021 with a negative result. The clinical outcome of swollen and tender axillary and pec lymph nodes, sore arm, right breast and right scapular area, right abdominal/flank pain and mild fever was resolving.   Information on the Batch/Lot number has been requested.
During a review of the Department of Health?s  records, it was found that there might have been a possible temperature excursion with how the vaccine was stored with our mobile vendor.
Depression, exhaustion, insomnia, edema, brain fog, bloating, constipation, lower back pain, muscle fatigue, muscle cramping
Narrative: THE PATIENT REPORTED THE SYMPTOMS STARTED ON THE 3RD DAY AFTER THE VACCINE 07/17/21. PATIENT REPOTED HAVING A SEVERE HEADACHE, NAUSEA, AND "SOARNESS ALL OVER." ON THE 4TH DAY SATURDAY 07/18/21 SHE REPORTED EXPERIENCEING SEVERE JOINT PAIN AND FELT THAT HER "PALMS WHERE ON FIRE".  PATIENT ALSO REPORTED THAT ON SATURDAY NIGHT SHE HAD A CAT SCAN DONE AND WAS TOLD SHE "HAD PNEUMONIA" THEY  RECOMMENDED SHE GO TO THE EMERGENCY ROOM. IN THE  EMERGENCY ROOM THEY DETERMAIED SHE DID NOT HAVE PNEUMONIA. BY STAURDAY SHE REPOTED VOMITING. PATIENT STATED BY THE 8TH DAY 07/19/21 SHE WAS FEELING "BETTER."
Vaccine administered at 10:55 am, at 11:02 am client had broke out with hives around the neck. EPIPEN Jr. auto injector used at 11:03 am and Ambulance called. Ambulance arrived at 11:08 am, breathing ok at that time. Ambulance departed with client to ER at 11:20 am.
Subconjuctival hemorrhage left eye.   Treatment- recommended to scheduled appointment with his primary care provider for further evaluation
3:30: The patient felt faint and appeared diaphoretic, blood pressure taken pt remained in sitting position AOx3. B/P 96/60, HR 65 02 sat 99%. 3;35 Patient remained in sitting position no c/o nausea. 3:50 Pt states feeling better is with Mother, encouraged to follow up with primary MD if symptoms return. final B/P 108/64, left with mother
Rash appeared on arm both at location site and slightly below. A little itchy. First noticed on Sunday, February 14, upon waking. Increasing in size and itchiness as of today - Monday, February 15. Looks like pictures of "COVID arm."
Information has been received from a licensed practical nurse concerning her girlfriend's 20 year old daughter with no medical history, who in November 2007, was vaccinated with a first dose of Gardasil. Within 20 minutes post vaccination the patient was in the waiting room and had a seizure. The patient vomited up to 2 or 3 times. An ambulance took the patient to the emergency room. The patient recovered on an unspecified date. No product quality complaint was involved. Upon internal review seizure was considered to be an other important medical event. Additional information has been requested.
This spontaneous report was received from a healthcare worker refers to a patient of unknown demography. On an unknown date, the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX23, lot # J006921 (expiry: 09-AUG-2014) (dose, route, and frequency were not reported). No adverse effect reported. No further information was provided. Additional information has been requested.