chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a consumer concerning her approximately 15 year old daughter with no pertinent medical history. Current condition of the patient included sulfa allergy. On an unknown date in April 2012 (about a year ago), the patient was vaccinated with dose 1 of 0.5 milliliter (ml) of GARDASIL (lot number and expiry date unspecified), intramuscularly. Approximately on an unknown date in 2012, the patient was vaccinated with dose 2 of 0.5 ml of GARDASIL (lot number and expiry date unspecified), intramuscularly. On an unknown date, the patient was vaccinated with dose 3 of 0.5 ml of GARDASIL (lot number and expiry date unspecified), intramuscularly. On 28-MAR-2013, the patient was inadvertently vaccinated with dose 4 of 0.5 ml of GARDASIL (lot number and expiry date unspecified), intramuscularly. Concomitant therapy included PRILOSEC. Approximately on 21-MAR-2013 (a week before the fourth dose), the patient experienced abdominal pain. However, after the fourth dose of GARDASIL, the medication had intensified the effect and had caused the patient to double over with pain. The patient was in so much pain that she had to go to an emergency room of an unspecified hospital. Since an unknown date, the patient was also experiencing involuntary twitching. The patient sought medical attention (went to an emergency room). The patient was treated with DEMEROL and with TYLENOL. On an unknown date, complete blood count (CBC) and urine tests were performed and the result was unknown. The patient had not recovered from the abdominal pain and involuntary twitching at the time of reporting. The relatedness for abdominal pain and involuntary twitching was unknown for GARDASIL. Additional information is not expected.
Heartbeat irregularities & "thumps" and intense headache -- both starting 6-8 hrs after injection and lasting  36 hours. Also chills but no fever.  Fatigue. I stayed in bed the entire next day.
Arm woke patient up and was very painful. Proceeded to be painful for a week after. Patient reports having to wear a sling for arm. Advil helps a little bit. Patient is trying to get in to see her doctor. Patient also says that neck is starting to hurt as well.
pt recv vax & exp nausea, vomiting, blotchy rash, fatigue, night sweats;ER or MD visit was required;sx persists;
This is one case out of a cumulative total of 221 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 20 December 2013. These 221 cases represent children who received 3 or more doses of Sanofi Pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Incident ID#: 1075338. Initial report received on 20 December 2013 from the Investigator participating in a study under the reference number M5A16. A case of pertussis disease in a 3-year-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3633AA received on 29 July 2010, lot number C3733AA received on 01 October 2010 and lot number C3813AA received on 06 December 2010, and 1 dose of DAPTACEL; lot number C3944AA received on 08 September 2011 (routes and sites of administration not reported). Approximately 14 months after the last dose, on 17 November 2013, the subject developed a cough and on 23 November 2013 a paroxysmal cough without a whoop. The subject also experienced sleep disturbance but no apnea. Laboratory testing included positive PCR on 25 November 2013. Chest x-ray findings were negative for pneumonia. Acute encephalopathy was unknown. Corrective treatments consisted of azithromycin starting on 25 November 2013 for 5 days. The subject was not hospitalized. At the time of final contact on 03 December 2013, the subject's cough was still persisting. The duration of the cough was reported at that time as 16 days. According to the investigator, this case was not epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
After I gave patient a shot, pt's father told my technician she was fainting. I came out to check on patient, She was conscious and talking normally, no sign of anaphylaxis thus we did not perform CPR, no EpiPen needed. Pt vomited and she got a lot better. We called 911 and paramedics came, and they decided she did not need to go to hospital. Father later on told me she may have been nervous from getting the vaccines.  I called father 4 hours later and he said patient already recovered.
1st vaccine- Fatigue,  migraine,  dull arm pain 2nd vaccine- Fatigue,  migraine,  dull arm pain, 3 periods in a month and a half, sharp pains throughout body leading up to 2 of the 3 menstrual cycle {1st period: spotting,  started 2 days after 2nd shot; 2nd period: heavy,  5 days late, pain throughout body; 3rd period: 3 days late,  debilitating pain throughout body for the 2 weeks leading up to period,  121 heart rate,  unable to stop shivering for 30 minutes, and heart burn.
Shortness of breath; Pain; Extreme chills; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath), VACCINATION SITE PAIN (Pain) and CHILLS (Extreme chills) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced DYSPNOEA (Shortness of breath), VACCINATION SITE PAIN (Pain) and CHILLS (Extreme chills). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, DYSPNOEA (Shortness of breath), VACCINATION SITE PAIN (Pain) and CHILLS (Extreme chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient have tested positive for the virus (COVID-19) after the first dose of the vaccine; Patient have tested positive for the virus (COVID-19) after the first dose of the vaccine; This is a spontaneous report from a contactable nurse via a Pfizer-sponsored program. This nurse reported same event for 20 patients (15 residents and 5 staff members). This is the third of 20 reports.  A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 03Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On Jan2021, the patient have tested positive for the virus (COVID-19) after the first dose of the vaccine. The nurse wanted to confirm when and if patient should receive the second dose. Outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event tested positive for the virus (COVID-19) based on the known safety profile. However the short duration since the vaccine first dose is given it is unlikely patient would have fully developed immunity.,Linked Report(s) : US-PFIZER INC-2021028829 same reporter, same drug/event, different patient
Patient was vaccinated with the Moderna Covid 19 vaccine past its best use by date; Patient was vaccinated with the Moderna Covid 19 vaccine past its best use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was vaccinated with the Moderna Covid 19 vaccine past its best use by date) and PRODUCT STORAGE ERROR (Patient was vaccinated with the Moderna Covid 19 vaccine past its best use by date) in a 50-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    In July 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In July 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was vaccinated with the Moderna Covid 19 vaccine past its best use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient was vaccinated with the Moderna Covid 19 vaccine past its best use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was vaccinated with the Moderna Covid 19 vaccine past its best use by date) and PRODUCT STORAGE ERROR (Patient was vaccinated with the Moderna Covid 19 vaccine past its best use by date) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  This case contains information of the 2nd out of 12th patients who received the vaccine on Jul-2022 as described by the reporter. Number of patients involved were 12 patients. Number of doses/vials reported  were 3 vials and 12 doses. The dates of administration and number patients were reported as on 16-Jul-2022 3 patients, on 23-Jul-2022 5 patients, on 24-Jul-2022 4 patients. All the vials were moved to fridge on the same day on 13-Jun-2022. The vial did not undergo any temperature excursions.  No treatment medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2022: Live Follow Up received, reporter details and narrative updated.
Muscle aches and pains all over body and fatigue.  Still ongoing.  800mg Ibuprofen taken daily.
Patient's lips blistered; hands, lips, nose and vagina became swollen. Patient had hives on arms, lower extremities were extremely tender, patient felt poking sensations over the body (felt like needles). Nose and throat became dry and patient felt out of breath and extreme fatigue. Patient had low blood pressure and extreme sweating. Patient went to urgent care and was given a steroid injection to reduce swelling and was diagnosed with bronchial spasms. Patient received a butanol treatment.
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and genders. No medical history, concurrent conditions and concomitant therapies were reported. On unknown dates, the patients received improperly stored ROTATEQ orally (lot #, expiration date and dose were not reported). No adverse effects were reported. No PQC (product quality issue) was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Moderna:  A few days soreness A few days a little red and itchy  A few days lymph node sore in my left armpit  Then on the 8th day the redness, swollen, warm to touch and the itching started and lasted 3 days. It was a lot of scratching.
This spontaneous report as received from a pharmacist refers to a currently 12 year old patient of unknown gender. Medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with (Oka/Merck) VARIVAX, lot number reported as J005693, expiration date 07-MAY-2015. Dose and route were not reported. No co-suspect and concomitant therapies were reported. The pharmacist reported that a dose of improperly stored (Oka/Merck) VARIVAX was administered to a patient (on an unknown date). No adverse effects have been observed. Additional information has been requested.
From telephone correspondence received at manufactuer on 12/11/02, it was reported that a 5 year old child received Tripedia (Lot # U0581AA) given in the left deltoid in August of 2002.  On to two days after vaccination, the pt developed swelling 3x size of arm.  The area was red, warm and painful.  It was diagnosed by the physician as Cellulitis.  No lab/diagnostic tests were needed, as it was very obvious.  The pt was not taking any other medication at time of vaccination, did not receive any other vaccinations within a 4 week time period, and did not have any illnesses or pre-existing diagnoses at time of vaccination.  The pt reportedly recovered from this event. The case is closed.  See cases U2002-00494, U2002-01159, U2002-01161 and U2002-01163 with same reporter.
flu like symptoms; chills; headache; Fever; Night sweats; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th July 2019, the patient received the 1st dose of Shingrix (intramuscular). In July 2019, less than a week after receiving Shingrix, the patient experienced influenza-like symptoms, chills, headache, fever and night sweat. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the influenza-like symptoms, chills, headache, fever and night sweat were unknown.   It was unknown if the reporter considered the influenza-like symptoms, chills, headache, fever and night sweat to be related to Shingrix.  Additional details were provided as follows: The patient experienced influenza-like symptoms, chills, headache, fever and night sweat. Fever reported was 102.4 F. Tylenol got the temperature down to 101.1 F. At the time of reporting the temperature was 100 F. The patient declined to provide demographics or follow up.
arrival of the shipment outside the acceptable 2-day window with no reported adverse event; children received doses of ActHIB that was deemed unusable later due to arrival of the shipment outside the acceptable 2-day window with no reported adverse event; Initial information received on 19-Apr-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves Infant patient of unknown age and demographics who received dose of HIB (PRP/T) vaccine [ACT-HIB] that was deemed unusable later due to arrival of the shipment outside the acceptable 2-day window with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection (strength, lot number and expiry date: not reported) via unknown route in unknown administration site as prophylactic vaccination (Immunisation). Information on the batch number was requested.  On an unknown date, a non-serious event arrival of the shipment outside the acceptable 2-day window with no reported adverse event (product storage error) (unknown latency), was reported.  On an unknown date, the patient developed a non-serious event children received doses of HIB (PRP/T) vaccine that was deemed unusable later due to arrival of the shipment outside the acceptable 2-day window with no reported adverse event (poor quality product administered) (latency: same day).  No lab data was reported.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event arrival of the shipment outside the acceptable 2-day window with no reported adverse event and was Unknown for the event children received doses of acthib that was deemed unusable later due to arrival of the shipment outside the acceptable 2-day window with no reported adverse event.   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 the guidelines. 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.; Sender's Comments:  2023SA124713:
On day 7 after shot, large red raised area around initial injection site. Raised area was hot, itchy, and firm for an additional three days, after which the area calmed down.
Redness in a circular pattern at injection site approximately 3.5 inches in diameter, soreness from left shoulder to elbow.
Patient developed muscle aches and runny nose on 7/24/2021.  He tested positive for COVID on 7/27/2021
Red, swollen, hot injection site. Fever/chills, myalgias, four days post injection. Given MEDROL - dose pak 9/17.
Employee came today to receive her second dose and asked me if she would have the same side effects as the first dose. When questioned she said she had a fever, which of course is a possibility, but she also said she had shortness of breath and it felt like someone was sitting on her chest for several days afterwards. She did not report this at the time, nor did she seek any medical treatment.
This spontaneous report as received from a physician refers of 2 patients of unknown demographics. The patient's current conditions or medical history were not reported. On an unknown date, the patients were vaccinated with ZOSTAVAX vial (dose, route, lot and expiration date were not reported). On an unknown date, the patients developed shingles. At the time of the report outcome for shingles was unknown. Additional information has been requested.
This spontaneous report was received from a physician concerning a 12 year old male patient that has never being hospitalized for asthma. On an unknown date the patient was vaccinated with a dose of M-M-R II (Lot #, dose and route unknown). Other suspect therapies included DTaP (unspecified), Tetanus Toxoid. The patient's mother reported that her child developed asthma after he received the vaccines. Also, the mother reported that on an unknown date and during an unspecified period of time after the child received the M-M-R II, his temperature was 104F.The physician stated that the child's diagnosis of asthma was not confirmed by him or any other physician, and he did not think that any medical attention has been has been sought. The physician also mentioned that he does not think that the child developed asthma because he was vaccinated. The physician was busy and he did not have the specific patient's information available at the time of the report. The outcome of fever and asthma was not reported and the causality between fever and M-M-R II was unknown. Additional information has been requested.
The location of the vaccination (right arm) became very hard, like large cyst. Patient began crying and expressed pain (boo-boo) on his right arm. Patient knows enough words to be able to communicate with my wife what was wrong. When she looked at the injection spot, it was very swollen and painful for patient. The cyst remained for more than a week (hasn't disappeared completely yet). We called the doctor's office and informed him of the reaction. Patient also received a vaccination in his left arm. Since the vaccination, patient has seemed to have a harder time concentrating and being attentive. I know that may sound absurd considering he's a 2 year old, but before the vaccination patient has been able to identify all numbers 0-9, all the letters of the alphabet and at least 15 different states on a Map (sometimes as many as 20). Since the vaccinations, patient has digressed in his ability & desire to identify the states. He also seems to space out more.
Pt received her flu vaccine around 3 pm on 11/30/2020. Later that night she developed a severe headache, fever of 101.6 and neck pain. She called the office the next day around 9 am and based on her symptoms was instructed to go to the nearest Emergency Room. She was diagnosed with meningitis. ( ER note state patient had Nausea and vomiting)
Patient was given a third dose of MMR and Varicella by receiving MMRV . Patient had a dose of MMR and Varicella at 12 months and then again at 18 months but the 12 month vaccine were not in our vaccine records. When vaccine record was printed form system it was noticed that MMR and Varicella had been give twice before.
pt. vax'd w/ 1st dose of hepatitis B vax & immed. exp. rash, urticaria, & hives covering body w/ flu synd & pain.
Eczematous type papule appeared at area of left bicep, and that area had ached for a month.-and still does sometimes.  The needle entered very high on the left arm.  It felt like the administrator of the vaccine hit a tendon or my bone!  She jabbed the deltoid very high  (too high) and very hard.  The second vaccine I had received three weeks later was given in the right arm, lower, and there has been no problem.
Pt recvd 3 doses of Engerix-B 20FEB91, 20MAR91, 29AUG91 & found to have not seroconverted; no tx given;
Patient received dose for ages 12 and above and is only 11. She had no abnormal side effects or anything really than minor arm soreness expected with any vaccination.
Report dizziness, tunnel vision, nausea started on 4/25 and blurred vision of the right eye started today 4/26/21. Treatment: checked blood glucose which was normal. Outcome: Currently at work, Slight improvement in symptoms. Will follow-up with primary care doctor.
A physician reported that a 33 month old male received Acel-Imune, Recombivax-HB (Merck) and IPV (Aventis Pasteur SA) vaccines on 3/3/00. Two days later, the child developed redness, swelling and tenderness at the site of Acel-Imune site. He recovered.