chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tested positive for Covid after first dose of vaccine; tested positive for Covid after first dose of vaccine; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 2 patients. This is 2nd of two reports (the husband). An 8-decade-old male patient received the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on 18Jan2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  On 03Feb2021 the patient tested positive for covid after first dose of vaccine. The patient lab tests which included sars-cov-2 test: Positive on 03Feb2021. The consumer stated they were both tested for Covid on 01Feb2021 and found out they were positive for Covid on Wednesday.  The consumer stated they were due to get second vaccine "yesterday", but are confused about when to get it or if they can get it, stated the doctor told them they could get it but she was calling to see what Pfizer had to say, stated they are confused. The clinical outcome of tested positive for Covid after first dose of vaccine was unknown.  Information on the Lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021137791 Same reporter/drug/AE and different patients.
A week after first dose, arm swelling double in size, hot to the touch, burning tingling feeling
Information has been received from a nurse concerning a 15 month old male who on 09-OCT-2008 was intended to receive VARIVAX, was inadvertently administered a single dose of ZOSTER vaccine (Lot number: 659407/0295X), SQ into the left thigh. On 09-OCT-2008, patient was administered the fourth dose of DTAP , IM into the right thigh (Lot number: C2955BA) There was no illness at the time of vaccination. There were no adverse symptoms or adverse reaction reported. The nurse confirmed this was due to nursing error and not product confusion. No further information provided. Additional information is not expected.
INJECTION SITE BLEEDING; This spontaneous report received from a patient concerned a 30 year old female. 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) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The Batch number was not reported. The company is unable to perform follow up to request batch/lot numbers.  No concomitant medications were reported. On 07-APR-2021, the subject experienced injection site bleeding. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection site bleeding. This report was non-serious.
Pt looked like she had fallen asleep and slumped in the chair. After arousing her, her skin turned green/grey. She reported dizziness, ringing in her ears, and nausea. Pt was given water to sip, a sucker, and observed for approximately 20-30 minutes. Mother took pt home after observation period. I followed up on 9/21/19 with a phone call. Mom was not home but pt was reported to be fine.
Seemed hypotonic after 2 month visit (has not recovered), developed seizure disorder with one week of 9 month visit. I will list vaccines from first visit on 13 and second (9 month) on 14.  As Per follow up report: Hypotonia, developmental delay.
Following vaccine on 8/30, woke up on 8/31 with terrible headache/flu symptoms, very sore arm and red forehead; 9/1-woke up with rash on chest and both sides of face and milder flu symptoms, sore arm; 9/2: rash diminished followed by itching on arms, face, neck and back, sore arm; 9/3: continued itching and sore arm; 9/4: red face returned, itching less and sore arm.
PT GOT BOOSTER DOSE ON 12/14/21 MORNING.  PT CALLED PHARMACY ON 12/19/21 AND REPORTED SOME ADVERSE EVENTS. PT SAID HE WOKE UP THE  NEXT DAY MORNING WITH  SWOLLEN LYMPH NODES ( FIST SIZE) IN THE LEFT ARMPIT. PATIENT SAID IT WAS PAINFUL WHEN PRESSURE WAS  APPLIED , THE SWELLING  GOT BETTER AND WENT AWAY IN 3 DAYS. ON 12/18/21 MORNING PT STARTED COUGH, CHEST TIGHTNESS AND NASAL CONGESTION. SINCE YESTERDAY EVENING  HE HAS ALSO BEEN EXPERIENCING SOME  EXTEND OF LOSS OF TASTE  TOO,
Red swollen large raised hard knot about 3 inches in diameter at injection site. Typical Covid arm. Red ring around. Itchy. Tried using Tylenol and Benadryl and ice.
Headaches; Bad rashes on top front of arms , neck and ear; Sinus issues/runny nose; Achey joints; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 68-year-old (non-pregnant) female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Batch/Lot Number: EP6955), via an unspecified route of administration, administered in arm right on 22Mar2021 (at the age of 68-year-old) at dose 2, single for covid-19 immunisation. Medical history included Known allergies: fresh strawberries and tomatoes, keflex, gentamycin. If covid prior vaccination: No. If covid tested post vaccination: No. If other vaccine in four weeks: No. Concomitant medications included levothyroxine sodium (LEVOTHYROXINE SODIUM); lisinopril (LISINOPRIL); glipizide (GLIPIZIDE). The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Batch/Lot Number: EM9809), via an unspecified route of administration, administered in arm right on 20Feb2021 at dose 1, single for covid-19 immunisation. keflex [cefalexin] and experienced known allergies: keflex, gentamycin and experienced known allergies: gentamycin. On 30Mar2021 the patient experienced headaches, bad rashes on top front of arms, neck and ear, sinus issues/runny, achey joints. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. Patient received treatment for the adverse events. Outcome of the events was not resolved.   Follow-up (26Jul2021): Follow-up attempts completed. No further information expected.
Patient received first his 3rd dose of the Pfizer covid vaccine on left arm. He seemed to be very nervous and anxious. After that he received Afluria vaccine on his right arm, he seemed dizzy just before the shot. When he got the shot, he turned pale and then very red. Instantly got dizzier, flushed on his skin, his body got very stiff, his fit seemed to shrink and urinated.
Initial pain with shot (not usually).  Shot was given much higher than previous.  It was given high on the shoulder approximate area was where your shirt sleeve may be sewn into the shirt body.  Took two Tylenol because of the unusual initial pain.  On Nov. 4, 2010 I notified Hospital about my symptoms and scheduled an appointment with my physician.  My physician was uncomfortable with the fact that I was having pain so long after my shot but asked that I wait a week to see if it disappated.  It did not so I contacted my physician again and she referred me to an orthopedist as the pain I am having feels like it is in my bones in my shoulder, down my left arm, and across my left clavicle.  I will meet with the orthopedist on Monday, December 6, 2010.  Other teachers in my building who received this flu shot are having similar issues.
fever, chills, nauseam headache, muscle aches Narrative:  Other Relevant History:
Abscess left thigh, soft to touch, pt does not wince when touched, has 3 erythematous areas on top according to mom had this bump since 7 mos old then said had it after 4 mos ago. Bump she said got bigger last week and pt refusing to walk.
Pt felt dizzy and got pale, never fainted, MD stated Pt always eating at school but had not eaten today. B/P 90/50, left clinic after 15 min and okay.
3-6 months post vax, the pt lost speech and eye contact. He also developed stimming behaviors (spinning, repetitive actions, etc). He also developed gastrointestinal symptoms and became intolerant of gluten and casein containing foods. He was a completely normal child prior to this IZ. He was dx with PDD under DSM III R on 9/1/87.
painful skin ongoing 4th day mild body ache ongoing 4th day fatigue ongoing 4th day     headache intermittent    intermittent cough      only treatment fluids and rest regular diet
A medical assistant reported that a female in her 50's received Td Absorbed vaccine and  TUBERSOL on 09-MAR-1999 and, the next morning, developed blurred vision and difficulty focusing her eyes. A copy of this report has been forwarded to PMC USA, manufacturer of TUBERSOL.
This is a spontaneous report from a contactable physician via a Pfizer Sales Representative. A 5-month-old male patient was administered a dose of PREVNAR 13 intramuscularly on an unknown date. Relevant medical history was unknown. Relevant concomitant medication was unknown. Vaccine given on the same day was unknown. Vaccines taken within the last four weeks were unknown. On an unknown date after vaccination, he experienced monococcal meningitis, ear infection and febrile seizure. He was hospitalized on an unknown date. The patient recovered from all events on an unknown date (s). Relevant lab data included blood work done on an unknown date and the results were unknown.
10 -15 minutes after shot: Swelling of tongue; drainage from nose and back of throat;gourde voice; trouble swallowing : elevated blood pressure  Told nurse 25 minutes later.given benedryl injection  Things improved and an hour later tongue began to swell again and blood press increased  Paramedics called and they transported me to the ER where I was given an Epi injection and steroids. Monitored for three hours and sent home with prescription for steroids: epi pen; and zyrtec  Still experiencing fatigue , headache and lots of drainage off and on
Area of redness erythema, warmth, induration 6x12 cm at area of immunization. Reported 48 hours later, resolved.
Pt reported localized erythema, warmth, edema and tenderness at injection site. At 10:30pm pt reported edema greater than expected from left shoulder to elbow lasted until 7:00am, shortness of breath 10:30pm until 1:00am. Treated with Tylenol and ice pack.
Pt granddaughter called and indicated that her grandmother had pain and redness radiating down her arm from the site of injection on the right arm.  They had to take her to ER and was given a cold compress.
After giving her the vaccines (FLUARIX QUAD and GARDASIL 9), patient told me that she felt dizzy. I noticed that her face looked pale and I felt her hands and that they were cold. I asked the patient to lie down in the chair and elevated her legs. She mentioned that she recalled having "the same reaction" when she was a child but forgot to tell me about it (she checked the "NO" box for that question (#3) in the Informed Consent for Immunization when I reviewed the form with her). She also reported that she was dehydrated before coming to the pharmacy (she teaches volleyball), hence I gave her some food and water to hydrate herself while waiting in the pharmacy waiting room. (Her PCP recommended her to get her GARDASIL injection hence the visit at the pharmacy). I checked on her for 30 minutes until she asked me if she can leave because she felt okay. I took her blood pressure with the machine we have in the room and her BP was 138/66 with pulse rate 75 before leaving. I offered to call somebody for her but she refused. She felt okay and there were no other signs or symptoms noted or reported before leaving the pharmacy. I called the following day to check on her but it led me to a voicemail box so I left her a message to give me call if she has any questions or concerns.
WITHIN 20 MINUTES PATIENT FELT DIFFICULTY BREATHING, LIPS ALMOST TINGLING, LIGHT-HEADEDNESS, COULD NOT BREATHE THROUGH NOSE
27NOV90 pt exp pain, swelling, chills, achy, a little dizzy & area was swollen w/lump lasted approx 2 days;
Pt. states that after receiving the 1st dose of Jansen J&J 11/15/2021, started experiencing symptoms 11/16/2021 of severe migraines/headaches, dizziness, extreme numbness in extremities, pain at injection site, difficulty moving arm (right), extreme nausea and fatigue, insomnia, "hallucination-like" visions, slight fever (100.0), and chills. Still continuing to experience symptoms, no noted Primary visit/communications.
Had MR on 21OCT91 & was reported slight fever & illness w/o one month of it being given;
Patient was vaccinated on 3/9/21 at facility in the morning. She developed a headache later that day. She woke up on 3/10/21 around 1145 with facial/neck swelling, urticaria,  and shortness of breath and presented to the ER at 1250. Upon arrival she was given 50mg benadryl IVP, 20mg Pepcid IVP, and 125mg Solu-medrol IVP. Soft tissue neck xray showed subglottic narrowing and thickened epiglottis. She had some improvement after IV medications but was admitted to ICU for observation overnight. She was discharged 3/12/2021 in stable conditions on steroids and antihistamines. Pt's vaccine card did not list vaccine lot number. I reached out to facility for the lot number and have not heard back.
Patient stated soreness for days, aching, chills, fatigue, and nausea.
Rash all over abdomen; Tired; Like a flu; Chills; Temperature/ Running temperature; Nausea; A spontaneous report was received from a consumer  concerning a 63-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced  chills, nausea, like a flu,  very tired, running temperature ,rash all over abdomen, still fever 99.9 -99.3 °F.   The patient's medical history, as provided by the reporter, included breast cancer of both sides and had a major surgery was under radiation treatment. Concomitant medications reported included letrozole drug used for unknown indication.   On 03 Jan 2021  prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K20A or 039L20A) intramuscularly  for prophylaxis of COVID-19 infection and On 03 Feb 2021  prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 028L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 03 Feb 2021, prior to receiving mRNA-1273, the patient felt chills, nausea, like a flu, running temperature , and on 04 Feb 2021  very tired, and on 05 Feb 2021 rash all over abdomen, still fever 99.9 -99.3 °F.   Treatment for the events included Alvin and Benadryl for rash. Action taken with mRNA-1273 in response to the events was not reported.   The events,chills, nausea, like a flu , were considered resolved on 03 Feb 2021 and the outcome of the events running temperature,very tired and rash all over the abdomen was unknown.; Sender's Comments:  MOD-2021-011677:Same patient, 1st dose of Moderna Covid-19 vaccine US-MODERNATX, INC.-MOD-2021-014794:Same patient, 2nd dose of Moderna Covid-19 vaccine
Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe. Additional Details: Patient came in with sore on her arm that looked like an oval area where her arm had been scraped. She said she was given the shot there, and it has been bothering her ever since (but it looked too low and immunizer said that is not where shot was given). She said it keeps bleeding every time she tries to clean it. I recommended some OTC products to help heal the area. She said she wanted to go to the doctor. I told her if she wanted to go to a doctor that would be fine.
Area of mal-discoloration, warmth, tenderness, edema 2X2 inch discoloration with 1.2 inch induration
Large red patch on skin same arm as injection.  Followed by blisters over the next day or two.  Looks like a burn.
past due for dose two, dose one in 2019; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in September 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as fllows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Pt. became pale, nausea and vomiting, unresponsive, altered mental status. Paramedics called to hm. Pt transported and admitted to hospital. Abnormal EEG, and also tests Dx: encephalopathy, lactic acidosis hemiplegic migraine.
p/vax pt exp localized react w/pain & swelling at inj site; also loss of mobility in lt shoulder; generalized pin in every joint; movement very painful; fatigue & unable to sleep; tx:Celebrex discontinued & tx w/medrol was initiated;
This study case was received from the investigator in a trial on 10 October 2013. A male subject with no relevant past medical history had received on 17 September 2013 an injection of ACAM2000 (lot number, route and site of administration not reported) and an injection of Anthrax vaccine (lot number, route and site of administration not reported) and on 21 September 2013 was found to have chest pressure. While laying down, the subject started to have chest pressure, got up and moved around some and it went away after 5-10 minutes. The chest pressure was very mild and worse while supine and occurred 2-3 times between 21 September 2013 and 22 September 2013. Troponin I on 23 September 2013 was normal at <0.10ng/ml. ECG on 23 September 2013 was unreadable due to equipment malfunction and myopericarditis could not be ruled out. The subject did not seek medical care, nothing alleviated the feeling and onset was sudden. The subject had no current symptoms, nothing triggered and it was described as pressure. The subject was not taking any medications and was referred to seek medical follow-up. No further information was available at the time of the report. The subject's outcome was recovered on 22 September 2013. According to the investigator the event of chest pressure was possibly related and the severity of the event was mild. Documents held by sender: None.
I have muscle pain where I received my vaccine. First I just thought it was painful from having the vaccine, but then it continued. I now have to watch how I use my arm, it feels at times as if my muscle is pulling/ripping. I have tried taking Ibuprofen and using muscle rub cream. I has been 2.5 months now and I still having problems. I have to watch how I use my arm, I can't prop myself with my arm, it hurts if I try to buckle my seat belt, or if I try to put my arm in my pocket. I also am limited to what I can do at the gym and it even hurts my arm when I run on the treadmill.
1st dose Dec2019, has not received 2nd dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 23rd December 2019).   On an unknown date, the patient received the 2nd dose of Shingrix 50 µg. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The patient's wife reported the case. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive his second dose, which led to incomplete course of vaccination. The reporter enquired if he still should get the 2nd dose of Shingrix. The reporter consented to follow up.
11/14/2003 Mother brought child for Hep B #3. Mother states 2 days after last Hep B shot, given 6/18/03, child had severe headache. Taken to ER. Would not go away. Blood tests showed no infection. Was released after several hours.
pregnant females that were given the invalid Adacel, no side effects observed; It was reported that excursion was caused by Human Error, The Excursion was Negative 40 degrees C and 22.7 degrees C/ There were no side effects observed.; Initial information received on 06-Sep-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case ID: 2019SA250866 and 2019SA250874 (same reporter).  This case involves a 25 year old female pregnant patient who was exposed to a second dose vaccine of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (dosage form: Prefilled Syringe) lot U6273AA, expiry date: 24-Apr-2021 via intramuscular route in the right arm on 21-Aug-2019.  The reported pregnant females that were given Adacel and no side effects observed occurred at unknown gestation period and the patient was exposed to DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE at 31 weeks of pregnancy, during third pregnancy trimester for DIPHTHERIA- 2/TETANUS/5 AC PERTUSSIS VACCINE. The date of last menstrual period was reported as 19-Jan-2019. The estimated due date is 25-Oct-2019. The patient previous pregnancy was not reported.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It is a case of vaccine exposure during pregnancy. It was reported that excursion was caused by Human Error, The Excursion was Negative 40 degrees C and 22.7 degrees C/ There were no side effects observed. Incorrect product storage.  It was reported that the patient had no adverse event following the vaccination.  Additionally, at time of reporting, the outcome of the pregnancy is unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error List of documents held by sender: none.