chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician, via a company representative, concerning to a patient of unknown age and gender. No concurrent conditions, medical history or concomitant medication were reported. On 14-JAN-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 with lot # L007720 Expiration date: 08-JUL-2018, 0.5 ml (route and anatomical location of administration were not reported). On unspecified dates, the PNEUMOVAX 23 vaccine had five temperature excursions of 0 Celsius Degrees (32 Fahrenheit) for 168 hours, 0.55 Celsius Degrees (33 Fahrenheit) for 128 hours, -1.11 Celsius Degrees (30 Fahrenheit) for 264 hours, -1.66 Celsius Degrees (29 Fahrenheit) for 256 hours, and -0.55 Celsius Degrees (31 Fahrenheit) for 472 hours, respectively. The vaccine status was reported as "in excursion" and the type of excursion and storage criteria were reported as "Refrigerator (R)". No adverse effects were reported nor Product Quality Complaint (PQC) was involved. This is one of several cases received from the same reporter. Additional information has been requested.
missed her 2nd dose due to migraine; This is a spontaneous case received from a contactable female consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient medical history included migraine from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. It was reported that she missed her second dose due to migraine, she wants to reschedule her second dose. She mentioned that her migraine was not related to vaccine. She already have this and it is on and off. The patient experienced missed her 2nd dose due to migraine and missed her 2nd dose due to migraine those from on an unspecified date. The clinical outcome of the events was unknown.  Follow up (15Mar2021): This is a Non Significant Follow-up spontaneous report received from a contactable consumer. No new information in source.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.  Follow-up attempts completed. No further information expected.
I did not have an adverse reaction to the vaccine. I tested positive for COVID-19 07/13/2022 with a home test. Starting feeling symptoms on 07/09/2022 like I was going to have a head cold. No fatigue, no stomach ache. I took TYLENOL for severe cold/flu.
Heavy cycles, period started a day early and there was no build up it was just heavy from day one .  It has never done that and it also was shorter, 4 days instead of typical 7 days. It also triggered my asthma which I have seasonal asthma and haven't had a flare up in 4 years and diarrhea 24 hr post vaccine.
Redness rash on right upper arm at the site of injection. Warm to touch. Apply cold compress and to follow up if condition continues.
pt reported "throat feels itchy and is tightening", epinephrine im given, vitals monitored Pulse ox 99-100%, Pt reported within 1 min of epinephrine administration, that she no longer felt that her throat was "itchy and tightening" response team arrived within 5 min, and pt was transported to ER
Patient came in for dose #2 of the Pfizer monovalent COVID vaccine on 11/17/2022 at around 4:30pm. She inadvertently received  a bivalent 5-11yr Pfizer covid booster instead of the primary dose. Contacted immunization website ask the experts and confirmed patient did not need to return for additional vaccine. Parent was notified of error and does not need to come back for additional vaccine at this time.
pt recvd vax 18MAR94 @ 1130AM & @2PM was crying until SOB, diarrhea, very warm to touch all over; 515PM phones hospital answering service to report sx; MD advised to give APAP & apply local cold to shot site if swollen; cried for 2 hrs;
Information has been received from a clinical medical assistant referring to a patient of  unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 04-OCT-216 , the patient received a partial dose of GARDASIL 9 (lot # L040054, expiration date 26-DEC-2017, dose and route unknown), as a result of a defective administration syringe. About a third of the dose leaked out of the syringe and didn't get injected into the patient. The dose of GARDASIL 9 was aspirated from the vial it was supplied in, so there was no product quality complaint (PQC). No adverse effect had been reported. Additional information has been requested.
they were all home sick with the flu; Initial information regarding this unsolicited valid non-serious social media case was received from a consumer and transmitted to Sanofi on 14-Oct-2020.  This case is linked to cases 2020SA291094, 2020SA291095, 2020SA291093, 2020SA291096, 2020SA291097, 2020SA291098, 2020SA291099 and 2020SA291100.  This case involved 5 patients who were all home sick with the flu (influenza), after they received vaccine INFLUENZA VACCINE.  Relevant medical history, past medical treatment, vaccination details and concomitant medication family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination. On an unknown date, it was reported that the patient always developed a non-serious flu, within 2 days following the administration of INFLUENZA VACCINE. It was reported that the reporter never had a flu shot and never had the flu, 28 years and 25 were kindergarten. The reporter had to help out with 5 subordinates. The reporter told a friend not to get it but the others talked her into it. When she got back she told the reporter that she was sorry she did not listen. She said never again. Relevant laboratory test was not reported. Final diagnosis was they were all home sick with the flu. It was not reported if the patient received a corrective treatment. At the time of reporting, the outcome was unknown for the reported event. There will be no information available on batch number for this case.
Narrative :COVID infections following completion of COVID vaccine series 02/12/21 COVID vaccine dose #1 03/05/21 COVID vaccine dose #2 03/21/2021 COVID preop test NEGATIVE 03/29/2021 Pt presents to ED for worsening swelling and difficulty swallowing with pain post-thyroglossal duct drain removal; admitted; COVID NEGATIVE 07/27/21 Pt presents to screening reporting cough x1 week (07/20), headache x1 week (07/20), and loss of taste/smell since 07/24; COVID POSITIVE 07/29/21 Pt reports only mild residual headaches; clinically resolved.
On day eight I developed COVID arm. At the injection site my arm is red, swollen, and very itchy.  It is a little painful.
Patient had primary rash around injection site on right upper arm, about 4 inches diameter. Secondary redness spread to elbow and erythema; faint. No further complications; patient seen by MD.
Patient received Pfizer as a 1st dose and Moderna as 2nd dose; a 13-year-old patient received Moderna as a 2nd dose; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (a 13-year-old patient received Moderna as a 2nd dose) and INTERCHANGE OF VACCINE PRODUCTS (Patient received Pfizer as a 1st dose and Moderna as 2nd dose) in a 13-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 01-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) at an unspecified dose. On 01-Sep-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (a 13-year-old patient received Moderna as a 2nd dose). On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Patient received Pfizer as a 1st dose and Moderna as 2nd dose). On 01-Sep-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (a 13-year-old patient received Moderna as a 2nd dose) had resolved. At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Patient received Pfizer as a 1st dose and Moderna as 2nd dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was provided by the reporter.
03/10/2012 mild other mother reports injection site was hot/swollen with a hard spot 2.5 inches in diameter.
A RASH OVER LEFT CHEST, TOP BOTTOM LIP, AND RIGHT SIDE; This spontaneous report received from a patient concerned a 60 year old female. The patient's weight was 325 pounds, and height was 67 inches. The patient's past medical history included a rash of the same type, and concurrent conditions included non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816022, expiry: UNKNOWN) dose was not reported, administered on 22-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-JUN-2021, the subject experienced a rash over left chest, top bottom lip, and right side. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from a rash over left chest, top bottom lip, and right side. This report was non-serious.
RASH STARTING ON LEFT ARM UPTO NECK; FEELING TIRED; SWELLING OF FACE; FEELING OF THROAT CLOSING UP; SWELLING OF LIPS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included hives. The patient was previously treated with diphenhydramine hydrochloride, fexofenadine, and prednisone. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021, the subject experienced swelling of face. On 19-MAR-2021, the subject experienced feeling of throat closing up. On 19-MAR-2021, the subject experienced swelling of lips. On 19-MAR-2021 23:30, the subject experienced feeling tired. On 20-MAR-2021, the subject experienced rash starting on left arm upto neck. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride, fexofenadine, and prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swelling of face, feeling of throat closing up, and swelling of lips on 20-MAR-2021, had not recovered from rash starting on left arm upto neck, and the outcome of feeling tired was not reported. This report was non-serious.
Had vaccine at 10am  on  a Monday. By 7pm, burning sensation on shoulder and chest. Put ice on it. Does not remember anything from 7pm  on Monday to 11am on Thursday. Describes brain as "going numb." Husband describes her personality as "changing." Much more fatigued. More aggressive than  usual (husband's description). More assertive than usual.
flu like symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 83 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Jan2021 (Lot number: EX931, Expiration Date: 30Apr2021) at the age of 82 years as dose 2, 0.3 ml single for covid-19 immunisation. Relevant medical history included: "COPD" (unspecified if ongoing), notes: Diagnosed probably before the year 2000; "Hypotension" (unspecified if ongoing), notes: Diagnosed about 3 years ago, borderline, sometimes he has hypertension too.; "Neuropathy" (unspecified if ongoing), notes: About 10 years ago; "one functioning lung" (unspecified if ongoing), notes: about two weeks after the surgery to remove the tumor.; "Tumor C2- C5", start date: 11Sep2001 (unspecified if ongoing), notes: Found out about the tumor 11Sep2001. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Lot Number:  EL0140 , Dose: 0.3ml, thinks it was the left arm., Expiration: 31Mar2021), administration date: 06Jan2021, when the patient was 82 years old, for Covid-19 immunization. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered", described as "flu like symptoms". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: No additional vaccines administered on same date of the Pfizer Suspect. Family Medical History Relevant to AE(s) were none. It was reported that patient got the 4th dose or booster dose and it was bit red. Patient had somewhat of a side effect from the second shot, he had flu like symptoms and went to bed and was fine the next day. This time he got the shot and the next day, he started getting achiness in his joints and went to bed early the achiness had somewhat there but improved but it was weird, he bent over to pick something up off of the floor and lost all balance, his legs went wobbly, whammed down and broke his coccyx bone. Later in the day, the muscular strength returned. It was like some short circuited his muscles, no electricity or anything, he lost control of his muscles. Patient lung doesn't function because of the frenetic nerve was nicked during surgery, he is getting old, two weeks after surgery his lung failed and he lost that lung. He has been going to a pulmonologist for a long time. In the emergency room, they took a fair amount of blood, and then put him into a machine, he thinks it was a CAT scan and then they took x-rays of his head, and down, they took x-rays of his lower spine and that is when they found the break of the coccyx bone.  Follow-up attempts are completed. No further information is expected.
On 22-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 12-Jan-2021 and the estimated date of delivery was 19-Oct-2021. On 19-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  first week of the pregnancy.  On 19-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient had three pregnancies before. Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medication was reported. No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-Mar-2021: Upon internal review on 20-Jul-2021, patient, products, events, analysis tabs and regulatory reports were updated.
No adverse event observed. Pt received Rotavirus is not to be administered after 14 weeks and 6 days. (Administrator event)
4 days, post vax, pt came to clinic with a large erythema rash on left lateral upper thigh, 6"-7" in diameter. It was hot and swollen at the injection site. Treated with Benadryl and Keflex 250 BID X 10 days.
8-24-07 pt received Gardasil HPV 1st dose patient had neg pregnancy test 8-23-07 pt returned to clinic 9-7-07 for pregnancy test which was pos at this time
The child received his second immunization with DTAP/HIB/IPB on February 9 at about 10 AM. He did well after the vaccine unto about about 1:45 PM, he suddenly became pale, limp, and hyporesponsive. The epidose lasted about 15-20 minutes, after which his color and muscle tone improved and he began responding normally.  No recurrences of the event have been noted He has remained afebrile.  I am the child's grandmother and I am also a Pediatrician with extensive experience with immunizations.  I witnessed the episode.  Note:  We contacted the clinic to get the lot numbers and they gave two lot numbers for Pentecel.
Potential Vaccine given >12 hour post vial puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Potential Vaccine given >12 hour post vial puncture) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Potential Vaccine given >12 hour post vial puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Potential Vaccine given >12 hour post vial puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was stated that one of their nurses gave a patient the first dose of the Moderna vaccine from a vial that was not dated appropriately. Initially it was said the vial was at room temperature for 6 hours and then given. And then the nurse indicated that she thought it might have been longer than 12 hours.  No concomitant medication reported. No treatment medication reported.
Headache, 9/10 severe abdominal cramping and dibilatating pain. Started 30 minutes after injection, lasted for 14 hours., unable to sleep or get comfortable. 3/10 dull abdominal pain from hours 14-24.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients (reported as approximately 50) of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates since 24-OCT-2016 (it was also the date of the temperature excursion), the patients were subcutaneously vaccinated with the improperly stored doses of PROQUAD (albumin status rHA, for prophylaxis, lot # M033209 with expiration date 09-JAN-2018, lot # M009746 with expiration date 23-AUG-2017, lot # M011660 with expiration date 08-SEP-2017, lot # M033215 with expiration date 09-JAN-2018, lot # M014302 with expiration date 22-SEP-2017; dose was not reported). No adverse effects were noted. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA014846.
Per patient, she went to see her PCP on 09/24/18 to get an Rx refill, but also addressed her sudden onset of headaches and hypertension. Patient stated she also complained of pain in left side of body and left side of head.
Patient reported feeling nauseated and dizzy Patient seen by medical team  Patient refused medical transport and signed AMA form Patient driven home with spouse
About 10:15am Pt received Hep B/Flu vaccine. 1030 pt returned with bright red macular rash arms, chest, neck, trunk denies SOB, denies chest tightness or dizziness, c/o 8/10 bilateral headache and feels very weak. Pt transported to medical center ER. Arrived at 1130am. Seen by MD at 1700, rash subsided at about 1130 am but HA still 5/10 and weakness. Spoke with units POX on Sunday Jan 8 2007. Pt back at unit states no after effects Pt can take 3rd Hep B when due per ER MD.
hive like reaction to arm around the site of the 2 injections.  area is itchy -started several hours after receiving vaccines
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown demographics. Patient's concurrent conditions or historical information were not reported. On an unspecified dates in February 2015, unspecified number of patients were administered with six doses of GARDASIL (lot# K009202, expiration date: 17-DEC-2016), 0.5 ml, intramuscular, (frequencies and routes not reported) that were exposed to temperatures outside of the recommended range. No adverse effects reported. Follow up has been received. The nurse stated that 5 patients received doses of improperly stored GARDASIL (lot# K009202, expiration date: 17-DEC-2016). Additional information was received from the registered nurse, concerning one out of five patients, namely a 12 year old female patient. She was vaccinated with improperly stored (temperature excursion) GARDASIL (lot# K009202, expiration date: 17-DEC-2016), intramuscularly on 14-FEB-2015. Additional information has been requested.
This spontaneous report was received from a medical assistant referring to a patient of unknown age. Information about drug reactions/allergies, concomitant medication and medical history was unknown. On 04-SEP-2018 the patient was vaccinated with VARIVAX (dose, and frequency unknown; lot # M037642 and expiration date 01-SEP-2018) for prophylaxis. Other suspect therapy included sterile diluent (dose, and frequency unknown; lot # reported as M040413 and expiration date 25-SEP-2018). The sterile diluent used to reconstitute the VARIVAX was not expired. No adverse events reported.
41 Year old female who received vaccination on 04/25/2003 in right deltoid.  Seen by employee health physician on May 1,2003 who reported that patient had increasing pain in the injection site area.  Patient has a history for smallpox vaccination as a child in 1961. Patient reported a fever of 102 but at doctor's visit she was afebrile (98.6).   Some lymphadenopathy reported and a palpable superclavicular lymph node was present on the right side.  Followed up with patient's physician, Dr. on May 7, 2003 and he reported that patient was improving.
Face flushed 10-15 minutes, post vax. Pt then slept about 2 hours and awoke with chills, high temperature and malaise. Has had anorexia and sore throat for 8 days. Seen by MD on 6th day. Improving slowly, day by day.
sore throat, nonproductive cough, body aches, nasal congestion. starting 12/21/21
Pt stated hives started 5/18/07 in the evening and became worse over the weekend.  Pt has taken Benadryl without any improvement. Referred pt to prescribing doctor for evaluation of symptoms.
low grade temp 99;red rash lt axillary region-rash persists 30hr later-noted 8PM by mom;no tx-saw family MD;
A few hours after flu shot, started getting numbness/paresthesia's and sharp/popping pain in (R) forearm. Since then, paresthesia remain, along with soreness at times of right forearm. Forearm, near wrist is slightly swollen and vein is distended at times, looks collapsed at times.
This spontaneous report received from the medical assistant referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. Medical assistant reported that an unspecified patient might have received an improperly stored dose of VARIVAX (lot: M048203; expiry date: 07-DEC-2018) (incorrect product storage). Temperature range was -14"C to-10"C for a time frame of 30 minutes. There was no previous temperature excursions. The call was because of a digital data logger. Medical assistant VARIVAX did not have a temperature excursion. No adverse effects were reported. Additional information has been requested.