chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 01-FEB-2017, the patient was vaccinated with improperly stored dose of PROQUAD lot # M033209, expiration date 09-JAN-2018, albumin status recombinant human albumin (rHA) (dose, route and site of administration were not reported). No adverse effects reported. Administered vaccine experienced the temperature excursion of -14.4 Celsius degrees for 54 minutes. There was no previous temperature excursion reported. Data logger was involved. This is one of several cases received from the same reporter. Additional information is not expected, all information has already been obtained.; Sender's Comments: US-009507513-1611USA004113: US-009507513-1611USA011831: US-009507513-1705USA009742:
Hospitalized 3 times since June 2021. Pneumonia and Sepsis. Given antibiotics and anti inflammatory medication. Inhalers
patient given Pediarix, 01-SEP-2021; patient given Pediarix instead of Twinrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 57-year-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number TN7S9, expiry date 29th May 2022) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st September 2021, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 1st September 2021, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The nurse reported that a patient inadvertently was given Pediarix instead of Twinrix, which led to wrong vaccine administered. The patient received Pediarix at inappropriate age which led to inappropriate age at vaccine administration. The reporter consented to follow.
Eye pressure; Light headed dizzy; Limbs feel like jello and wobbly; Felt like I was floating as if I was 10 feet tall; Sugar bottomed out to 80; Fast heartbeat; Shaky hands and legs; This is a spontaneous report from a contactable Other Health Professional (patient herself). A 57-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), dose 1 via an unspecified route of administration, administered in right arm on 02Feb2021, 07:30 AM (Batch/Lot Number: EL9261) as 1st dose, single for covid-19 immunization. The patient's medical history included Diabetes mellitus type 2, Fibromyalgia, Hypothyroidism, Osteoarthritis, allergies to Penicillin from an unknown date. The patient received other medications within 2 weeks of vaccination. On 02Feb2021 at 11:30 am, 4 hours after the vaccination the patient experienced Eye pressure, Lightheaded dizzy, Limbs feel like jello and wobbly, felt like she was floating as if I was 10 feet tall, Sugar bottomed out to 80, Fast heartbeat and Shaky hands, and legs. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. No treatment was received for the events. The outcome of the events was Recovering.  Follow-up attempts are completed. No further information is expected.
Left arm Swollen from shoulder to elbow twice the size as normal. Benadryl & ice & antibiotic
With each vaccine, (I have had both shots and the booster) I have had reactions with my menstrual cycle.  Once my cycle was finished, I would start again a week later.  And since my booster on 11/19/2021, my period has almost been non stop at this point.
I have nodules on my armpit; lumps kind of like swollen up; it's kind of full of pain till now; I am concern about it; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old male patient received bnt162b2 (BNT162B2), administered in hand right, administration date 24Sep2021 (Lot number: FC3184, Expiration Date: 07Oct2021) at the age of 49 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Heart burn" (unspecified if ongoing); "Blood pressure" (unspecified if ongoing). Concomitant medication(s) included: OMEPRAZOLE taken for burning sensation; LISINOPRIL taken for blood pressure abnormal. Vaccination history included: Bnt162b2 (First Dose,, location: left arm, Expiration date: 28Sep2021), administration date: 03Sep2021, when the patient was 49 years old, for Covid-19 immunization. The following information was reported: NODULE (non-serious), outcome "unknown", described as "I have nodules on my armpit"; SWELLING (non-serious), outcome "unknown", described as "lumps kind of like swollen up"; PAIN (non-serious), outcome "unknown", described as "it's kind of full of pain till now"; ANXIETY (non-serious), outcome "unknown", described as "I am concern about it".  Additional information: Patient took 1st shot 3 weeks ago and 2nd shot on Friday so, she thinks from the second shot, she was having this reaction. Consumer stated, "So you want me to call my provider and check on what they going to say." Consumer was advised for to call doctor in case of any emergency and for query consumer was requested to call Medical Information.  No follow-up attempts are possible. No further information is expected.
Approximately 5 inches of swelling, redness, and warmth to arm site - covering circumference of arm.
This spontaneous report as received from a physician to a patient of unknown age and gender. Pertinent medical history and drug reactions or allergies were unspecified. On an unknown date the patient was vaccinated with an improper stored M-M-R II (strength, dose, route, dose number and lot number were not reported). Concomitant medication was unspecified. No adverse events reported at the time of this report. The outcome of the event was unknown. The physician also reported that another patient may have been vaccinated with improperly stored VAQTA (see MARRS 1406USA010224). This is one of several reports received from the same reporter. Additional information is not expected.
one of the nurses at the outpatient clinic where she works was positive for covid; Nausea; she started feeling a little warm; Low grade fever; Chills; This is a spontaneous report from a contactable nurse reporting for herself. A 67-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3302), intramuscularly on 19Jan2021 11:03 on right arm at single dose for COVID-19 immunization. Vaccination Facility Type was at Clinic. Medical history included just had rotator cuff repair surgery last Thursday (11Jan2021), pain, muscle relaxer. Concomitant medications included acetaminophen; hydrocodone as pain medicine, methocarbamol as muscle relaxer. Historical Vaccine included first dose of BNT162B2 (Lot number: EK9231) intramuscularly on 28Dec2020 at 9:52 am for COVID-19 immunization on right arm and experienced right arm soreness at the injection site. It was reported that last night (19Jan2021) she had a low grade fever and chills, then it went away, she was not having the chills earlier today and the fever went away. The fever had come back and she was chilled even though it was hot. She tested negative for coronavirus that Monday (08Jan2021) prior to the surgery. She was being told that one of the nurses at the outpatient clinic where she worked was positive for covid. She clarified that the fever and the chills go together and started last night. The fever did get better and she was not feeling feverish or chilled during the day. About 2 or 3 hours ago (20Jan2021) she started feeling a little warm, nauseated and she checked her temperature 30 minutes ago and it was 99.4. She always run low and did not have a fever. No treatment received for all events. The outcome of event low grade fever was resolving, outcome of events chills and nauseated were not resolved, outcome of other events were unknown.; Sender's Comments: A possible contributory effect of suspect BNT162B2  on reported events low grade fever, chills and nausea cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Rash similar to what patient got after viralinfection started on Monday 4/19; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the left arm on 17Apr2021 at 15:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included eczema, penicillin allergy and sulfur drug sensitivity. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications were not reported. The patient previously took BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 27Mar2021 at 08:30 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. On 19Apr2021 at 21:00, the patient experienced rash similar to what the patient got after viral infection. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event rash similar to what the patient got after viral infection was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Pt recvd vax 29APR92 11AM; pt devel malaise, fever to 99.8, mild abd pain 13 hrs p/vax; no rx necessary;
A patient who received the first dose of the Moderna COVID-19 vaccine in February did not receive their second dose till date, more than 35 days past the first dose.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (A patient who received the first dose of the Moderna COVID-19 vaccine in February did not receive their second dose till date, more than 35 days past the first dose.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (A patient who received the first dose of the Moderna COVID-19 vaccine in February did not receive their second dose till date, more than 35 days past the first dose.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (A patient who received the first dose of the Moderna COVID-19 vaccine in February did not receive their second dose till date, more than 35 days past the first dose.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Follow-up received on 19-Jul-2021 and does not contain any new information.
10 days p/shot had temp of 102.6, ER when arrived; adverse react was collapsed stopped breathing-turned blue, needed stimulation & some chest compressions; then had a sz & vomitted afterwards then became unconscious;
Patient was vaccinated on 14MAR21 at 2000.  At 2230, the patient returned to the vaccine room complaining of fatigue and nausea.  He was evaluated and monitored by one of our registered nurses for 30 minutes before going home.  He had a friend drive him home.  He will follow-up with our onsite nurse as needed.
Information has been received from a physician concerning a 13 month old female old female with port wine naevus and sensitivity to OMNICEF who on 23-JUN-2008 was vaccinated with MMR II, IM. Concomitant therapy included "unknown other vaccination" (therapy unspecified). On 23-JUN-2008 the patient developed a golf ball size knot at the injection site. She was treated with ice packs and TYLENOL. Ten days after vaccination the patient developed a rash all over her body and a slight fever. The rash was diagnosed as measles. The patient also developed an eye infection which is being treated with unknown eye drops. It is reported that the patient is recovering from the events. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Tongue started to swell @ 430PM; Started trembling, gums blue; couldn't breathe well; seen in ER;
Recd DPT, OPV, & HIB on 16SEP91; 18SEP91 sz x 1-2 min; hospitalized;several szs since then;
Narrative: Headache, Myalgia, sweating/chills, right arm sore
I contracted COVID on 03/11/2022, I really did not have a lot of symptoms, but I was having trouble like my lungs hurt. It was like pleurisy, and I had a bit of a cough. That started on a Friday and had a infusion on a Tuesday. After a week or so I started feeling well. It was about a week I felt. I had an actual infusion instead of the pills. I thought the infusion was interesting, there was many people going in and out. I noticed that no-one had many symptoms, but did have underlying conditions.
2 day after IM injection deepen with erythema of Left deltoid. 6 day after immunization in our clinic with 15x10cm erythematous/itchy/non tender patch on Left deltoid. Treated with Benadryl and ice (Dtap) site.
Developed petechial rash 5 days after vaccines. Labs normal. Unclear etiology. Hep B listed petechiae under rare/case report. Dtap and Rota lists thrombocytopenia as possible reactions but labs are normal. Likely viral process.
Info has been received from a consumer concerning a 12 y.o. female PT w/no known drug allergies, who in July 02 was vax'd w/Hep B vax recombinant. There was no concomitant medication. Subsequently, 2 days post vax w/Hep B vax recombinant the PT developed leg pain and could not walk on her leg.
Patient came into the pharmacy with the Mother to check in for her Covid Booster shot.  Technician asked what vaccine and mother requested for Moderna and the technician wrote it down on the consent form.  The pharmacist overlooked that the patient is not yet 18 years old yet and had allowed the shot to be administered by a visiting nurse. The mom was notified and was not aware of the age limit but said that her daughter was almost 18 years old in 2 months.  Explained to Mom that the vaccine was indicated for patients age 18 and older.
Localized injection site redness, swelling after immunization left upper arm approx 10cm x 9cm.
delayed cutaneous hypersensitivity reaction  Narrative:  rash appeared (irregular border, hard to touch) about 6 days after the dose.
Woke out of sleep with bad  chills.  Had fever because my body was very hot.  I had body aches.  I didn't roll over onto my sore arm.  I had a headache.  I only got out of bed to use bathroom, couldn't eat anything for 1 day.  symptoms remained for about 24 hours.  3 hours into it i took tylenol -that helped.     In the beginning I felt nauseous.  I knew it would end, but it was very difficult during that time.   It took about 2 days after to feel back to normal.
On Friday, 1/8/16 he was delusional, weak, some diarrhea, heart palpitation and did not feel well. Was sent home from school. Slept a few hours then felt better. On Saturday 1/9/16 he had rapid heartbeats at about 6:15 pm was dizzy, had headache, anxious, nervous felt weak, had to walk to get heart rate back to normal. Took him to the Emergency room at hospital. They monitored him there.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          On Friday, 1/8/6 8:10 AM he was delusional, weak, some diarrhea, heart palpitation, and did not feel well. Was sent home from school. Slept a few hours then felt better. On Saturday, 1/9/16 he had rapid heart beats at about 6:15 pm was dizzy, had headache, anxious, nervous felt weak, had to walk to get heart rate back to normal. (Took him to the Emergency Room at hospital, monitored him there.
sore arm at injection site, fatugue, general malaise,  neck soreness on side of injection
4/6: 10 a.m. soreness at injection site, fully subsided by afternoon  of 4/8 4/6: 6:00 p.m. moderate pain in knees and hip joints, moderate nausea began 4/6: 10 p.m. fever, moderate pain in knees, lower back, migraine-like headache, extreme pain in hip joints, unable to get comfortable or sleep due to severe pain 4/7: moderate pain in knees, pain in hips continued all day, low grade fever, intermittent headaches, interfered with daily activities, unable to work 4/7 10:00 p.m. able to sleep after 100 mg Tylenol reduced pain/headache, woke up at 2 a.m. with joint pain increasing, moderate intensity but able to sleep through it 4/8 all day mild joint pain continued, but did not interfere with working, headaches subsided and nausea mostly gone
9 days after the first Moderna vaccine, red inflamed patch appeared at the injection site, and 3 inches in diameter. No itching or soreness.
patient reports tachycardia for 2 days when resting employee  reports heart rate was between 100-110 but increased to 120 when employee sat up or got up.  Fever of 100.9 for 1 day and chills for 3 days.  Sharp and Throbbing headache for 3 days with lightheadedness on and off for 4 days.  Injection site arm was itchy .  Employee reports taking tylenol, zinc, vitamin D and Vitamin C
12:16 PM (2 hours ago) to me      Just to let you know that I tookHER to the doctor, they did EKG and he said that SHE had tachycardia. Unfortunately, the doctor said that he has been seeing this in young patients after they get the Covid vaccine. These are unacceptable side effects I did not want HER to go through.
This spontaneous report as received from a Licensed practical nurse refers to unspecified number of patients of unknown demographics. Patiens concurrent and relevant medical history was not reported. The reporter stated that, on an unknown date, unspecified number of patients were vaccinated with improperly stored doses of GARDASIL (lot number, dose, frequency and route unspecified). Concomitant medications were not reported. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with suspect therapy was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
Exactly 1 week from time of Rotavirus vaccine on 10/16/06 infant developed profuse diarrhea that was slimy and had horrible odor. Mother used 48 diapers in 2 days. Saw doctor 1 day after diarrhea started. States saw doctor 3 times during illness. Diarrhea lasted for one month.
Patient developed a fever of 105 (rectally) the evening of administration.  He also developed mild congestion, and had a mild cough.  He was seen in the office the following day, and had only a subjective low-grade fever that day, and had a mild red throat on exam.  The rest of his exam was normal.  A rapid flu and a rapid strep test were both negative in the office.  A CBC showed a white count of 9.2, H/H of 11/33, and platelets of 249.  There were no known ill contacts at the time.
Bells palsy affecting right side of face. Prednisone 20mg PO BID x 10 days. Then 20mg PO q x 4 days.
Muscle weakness that same night. The next day I had muscle weakness, a headache, hot and cold flashes, nausea, a knot in my chest (if you eat peanut butter too fast the feeling of it being stuck in your chest) for a week afterward, and difficulty eating or being able to tell when I?m full (it knocked my senses out of whack and I couldn?t really tell).
COVID-19; Up all night, couldn't sleep; Awful dry cough; Sore left shoulder; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), INSOMNIA (Up all night, couldn't sleep), COUGH (Awful dry cough) and ARTHRALGIA (Sore left shoulder) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (unknown route) 1 dosage form. On 19-Jan-2021, the patient experienced ARTHRALGIA (Sore left shoulder). On 22-Jan-2021, the patient experienced INSOMNIA (Up all night, couldn't sleep) and COUGH (Awful dry cough). On 25-Jan-2021, the patient experienced COVID-19 (COVID-19). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (DAYQUIL) at a dose of 1 dosage form; DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) at a dose of 1 dosage form; FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) at a dose of 1 dosage form and CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) at a dose of 1 dosage form. On 24-Jan-2021, COUGH (Awful dry cough) had resolved. At the time of the report, COVID-19 (COVID-19), INSOMNIA (Up all night, couldn't sleep) and ARTHRALGIA (Sore left shoulder) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2021, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
I took my mother to get her booster shot; she did not feel well after and felt ill until she was taken by ambulance about two weeks later to hospital; At that time they said she had internal bleeding in her abdomen and took her off warfarin after 5 day stay in the hospital; she was sent home but still did not feel good flu like symptoms; she died of a cardiac arrest in the ambulance when they were called two days after her release from hospital.  I don't believe we ever thought to tell the hospital she had just received her booster before falling ill and it did not register with me until today that she had flu symptoms directly after and just got sicker and sicker until she died on June 20, 2022 less than a month after booster at Hospital