chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial and follow-up information has been received from a nurse practitioner through the pregnancy registry concerning a 17 year old female with a history of an elective termination of a previous pregnancy, and with borderline anaemia, Trichomonas, and no drug allergies, who on 24-JUL-2007 was vaccinated intramuscularly with a 0.5mL first dose of Gardasil. Concomitant therapy included vitamins (unspecified), ferrous sulfate, and metronidazole. Subsequently, the patient was determined to be pregnant. No problems were reported. The patient's last menstrual period was reported as the end of June 2007. The patient was examined in the office. On 20-SEP-2007 the patient had a spontaneous abortion approximately "10 to 12 weeks" from the last menstrual period. The methods of conception were not examined. During the pregnancy the patient had Trichomonas which was treated with metronidazole 500mg, two times a day for 7 days. The treatment was started on 24-JUL-2007 and 20-SEP-2007. On 24-SEP-2007 an ultrasound was performed due to bleeding and the results showed empty gestational sac versus an embryonic pregnancy implying that an early spontaneous abortion was in progress. The patient had one previous pregnancy that resulted in an elective termination. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Upon internal review spontaneous abortion was considered to be an other important medical event. Additional information is not expected.
Chest pain on left-side with numbness in arm started less than week after 4th shot. Went to emergency room; told no heart issues and sent home.
Pt developed lower abd pain radiating to (R) thigh on 9/21. Normal exam. Then complained of myalgia (L) arm and both legs on visit 9/29. Normal exam and labs. By 10/3, marked improvement. Back to normal activities.
My husband sick in the bed; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (My husband sick in the bed) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 084J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (My husband sick in the bed). At the time of the report, ILLNESS (My husband sick in the bed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported by the provider.
redness at the injection site that spread to elbow; Pain; Itching; Swelling; Warm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (redness at the injection site that spread to elbow), VACCINATION SITE PAIN (Pain), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE WARMTH (Warm) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness at the injection site that spread to elbow), VACCINATION SITE PAIN (Pain), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE WARMTH (Warm). On 05-Feb-2021, VACCINATION SITE PAIN (Pain) and VACCINATION SITE PRURITUS (Itching) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (redness at the injection site that spread to elbow), VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE WARMTH (Warm) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. Treatment details was reported as hydrocortisone 2.5% cream and ice for several days.   This case was linked to MOD-2021-017279 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Feb-2021: No specific follow-up information recorded.
The pt felt dizzy, faint, was pale. After 15 minutes the pt felt better. Also drank water.
had pain on top of the right eye brow; cellulitis  of the right eye socket; cluster of blisters/cluster of blister and rash near the right hip towards the back; rash near the right hip towards the back /  rash on top of the right eye brow; This case was reported by a consumer via call center representative and described the occurrence of cellulitis in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number 23LD9, expiry date 2nd April 2022) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 5 months ago from reporting date).   On 4th March 2020, the patient received the 2nd dose of Shingrix. In March 2020, 1 week after receiving Shingrix, the patient experienced cellulitis (serious criteria GSK medically significant), blister and rash. In August 2020, the patient experienced pain. The patient was treated with clindamycin, methylprednisolone, levothyroxine sodium (Synthroid), metformin and vitamins nos (Multivitamins). On an unknown date, the outcome of the cellulitis, blister and rash were recovered/resolved and the outcome of the pain was unknown.   It was unknown if the reporter considered the cellulitis, blister, rash and pain to be related to Shingrix.  Additional details were reported as follows: The patient received 2nd dose in left arm. The patient got the 2nd dose of the Shingrix vaccine and 1 week later she had a cluster of blisters and rash on top of the right eye brow with cellulitis  of the right eye socket. She was seen by a dermatologist 3 days later who started her on 10 days of clindamycin and 4 days of methylprednisolone.  This events were resolved in 2 weeks. Later 5 months after the 2nd dose of the Shingrix vaccine, patient observed cluster of blister and rash near the right hip towards the back which she treated with a band aid. She did not visit a doctor and this resolved in 2 weeks.  The patient stated that she received the 1st dose of the Shingrix vaccine about 5 months ago but she did not remember the date. She reported that about 1 week ago she again had pain on top of the right eye brow but was not diagnosed with shingles. The patient did not have previous episode of shingles. She stated she only takes synthroid and metformin with some multivitamins The reporter consented to follow up.
Swollen hive-like welt down the arm, very sensitive, massive headache for almost 24hours, exhaustion and total fatigue, malaise and disorientation. First injection was given incorrectly and was administered subcutaneously and had the bad welt but not the same sickness.
Sometime after the vaccine, I had a headache that was so bad, that was in the center of my forehead. It was so intense that it would wake me up in the middle of the night. Body aches, sore throat, and then I started having difficulty breathing. I went to the clinic and tested positive for COVID. I took PAXLOVID and was feeling a lot better. Then when I was off of that, it came back. The headache, the chills, I also had stomach problems this time around and the trouble breathing was more intense that I had to use my stronger inhaler. I also had severe fatigue. Nothing was as bad as the headache. The second time around I did start coughing and so I went to the urgent care that sent me to get an X ray to see if I had pneumonia but luckily that came back negative.
Individual was known to be 29 weeks + 3 days pregnant at time of vaccination and should, therefore, not have received varicella vaccine. The screening question "Are you pregnant or is there a chance you could become pregnant during the next month" was appropriately checked yes.  The vaccine consent form indicates that the individual received varicella vaccine as this line item is initialed and the administration site was circled as right left arm.  When discussion this incident with the vaccination team, the team reports that this was a documentation error, and the individual did not receive the varicella vaccine. This individual was vaccinated during a mass vaccination effort (>400 individuals vaccinated over a two-day period of time and > 1600 vaccine administered), meaning that it's difficult to truly know if the vaccine was not given as the medical team verbally reported.
headache; short of breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (short of breath) and HEADACHE (headache) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination.     Concurrent medical conditions included Urinary tract infection since 15-Apr-2021.   On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-May-2021, the patient experienced DYSPNOEA (short of breath). On 15-May-2021, the patient experienced HEADACHE (headache). The patient was treated with PHENAZOPYRIDINE on 29-Apr-2021 at a dose of 100 mg three times a day; OXYBUTYNIN on 29-Apr-2021 at a dose of once a day for 14 days; CIPROFLOXACIN on 13-May-2021 at a dose of 500 mg twice a day and MIRABEGRON (MYRBETRIQ) on 13-May-2021 at a dose of once a day for 7 days. On 15-May-2021, DYSPNOEA (short of breath) and HEADACHE (headache) outcome was unknown.            No concomitant medications were reported.  Treatment also include sage juice daily, carrot, lemon, curcuma and ginger juice daily.   This case was linked to MOD-2021-163654 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: TCR contains NNI, where reporter stated she does not have computer and access to email or fax
No adverse reaction to the patient just a medication error, the patient was vaccinated twice 1st on 3/29/12 then again on 3/31/12. The root cause is being investigated by the hospital for process improvement. Dr will monitor patient for possible reaction but no reaction to date.
Tenderness around injection site. Extreme lethargy and depression for ~ 48 hours after injection.
About 2 minutes after client received Pfizer dose, he had an episode of syncope and became unresponsive for about 3 seconds.  Client recovered and had stable vital signs during a 30 minute observation period.  No apparent physical injury occurred with the fall.
For 6 hours my skin was extremely sensitive and  painful to the touch and I couldn?t sleep. It hurt if I touched my skin, if my clothes touched it, if a blanket touched it. It was all over my body.
I had a sinus infection the week before the shot. I took a prescription antibiotic "Z pack" to treat the infection. It started to go away. I got the shot on Monday, 4/24/06. On Thursday, 4/27/09 the sinus infection came back. All symptoms resolved as of 5-19-2006.
COVID 19 Treatment; COVID 19 Treatment; vaccine brand: Pfizer/BioNTech / vaccine brand other: Moderna; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown) and in May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 27 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) and in Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset Nov2021, outcome "unknown", described as "vaccine brand: Pfizer/BioNTech / vaccine brand other: Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid (Treatment start date: 17Dec2022, Treatment stop date: 21Dec2022).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
2nd dose passed the recommended 25 days to 35 days after dose 1; Shingles; A spontaneous report was received from a healthcare professional dear concerning a 44-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced shingles, second dose passed the recommended 25 days to 35 days after dose 1.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 15 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 024M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 18 Mar 2021, the patient experienced shingles. On an unknown date, the patients second dose passed the recommended 25 days to 35 days after dose 1.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of shingles was not recovered and for missed dose recovered.; Reporter'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.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. Information about concurrent conditions, concomitant medication and medical history was not provided. On an unspecified date the patients were vaccinated with doses of improperly stored oral, ROTATEQ (lot#, dose and frequency were not provided) orally. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Vaccines administered at 10:00 AM. Initially did not complain of any adverse side effects but 2-3 minutes after injections, stated he felt that he was going to pass out. Became diaphoretic and pale but was able to answer questions appropriately. Lost consciousness at 10:05 AM and was transferred to cot, supine position, with legs elevated. Cold packs placed to bilateral axila and posterior neck. Fan placed on client. At 10:20 AM, client stated he was feeling better. At 10:26 AM, assisted to sitting position on cot. At 10:32 AM, assited to walk to bathroom as he felt need to urinate. At 10:40 AM, assisted to car, gait steady.
COVID-19; feeling ill; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feeling ill) and COVID-19 (COVID-19) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe).   On 15-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2022, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 27-May-2022, the patient experienced MALAISE (feeling ill). On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, MALAISE (feeling ill) and COVID-19 (COVID-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant drugs are not reported.  On an unknown date in 2022 patient experienced COVID-19 after taking COVID vaccine. It was unknown that patient was enrolled in COVID-19 vaccine trials.  Action taken for Co-suspect drug was reported as Dose not changed and causality as not reported. Dechallenge reported as Not applicable.  No treatment medication information provided.  Company Comment: This is a Spontaneous case concerning a 52-year-old female patient, with no relevant medical history, who experienced the unexpected and non-serious AESI of COVID-19, which occurred approximately 4 to 7 months after the first dose of mRNA-1273 vaccine. Patient also received adalimumab (Humira) at an unspecified dose for Rheumatoid arthritis, remaining as a co-suspect product. No information disclosed regarding clinical course, diagnostic tests performed or treatment received. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a Spontaneous case concerning a 52-year-old female patient, with no relevant medical history, who experienced the unexpected and non-serious AESI of COVID-19, which occurred approximately 4 to 7 months after the first dose of mRNA-1273 vaccine. Patient also received adalimumab (Humira) at an unspecified dose for Rheumatoid arthritis, remaining as a co-suspect product. No information disclosed regarding clinical course, diagnostic tests performed or treatment received. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Patient tolerated vaccine well until 2 hours after. He screamed a bizarre scream, eyes glazed over, lethargic and limp/listless for about 72 hours. Decreased interest in breastfeeding. On day 3, he began to "bounce back." Patient now with speech delay/language delay. When I told MD about vaccine response, she urged VAERS. No idea it was abnormal MD said "normal".
During well visit at 2 months, patient was given shots HIB and Prevnar.  He has a bump and slight swelling on the leg that was injected with the Prevnar shot.  Less than 24 hours later I noticed that he was moaning and he felt warm.  The doctor said that he might get a slight fever, so I wasn't too alarmed, but that night his fever reached 103 degrees and he didn't sleep much, just seemed to be lethargic.  He couldn't focus on anything and the moaning got worse.  He developed a rash on his chest and didn't want to eat much.  In the morning I called the doctor to take him and she heard him moaning on the phone and wanted me to take him to the emergency room.  I took him and he was given many tests to diagnose his condition including a Spinal tap, strep culture, lab work, urinanalysis, chest X-Ray, and fluids through an IV.  Patient was admitted to the pediatric ward for 3 days.  His fever would come down with Motrin, but then would go back up again when the medicine would wear off.  His fever finally stayed down and we were released after 3 days.  He had the fever for 5 days though.  The rash went away and he returned to normal.  Patient was completely healthy before the immunizations were administered.  8/31/07 Received vax record which included lot #s.  VAERS database updated w/same./ss 9/11/07 Reviewed hospital medical records which reveal patient experienced fever, cough, moaning, constipation & rash x 2 days.  Admitted 8/2-8/5/07.  Full septic w/u was WNL.  Treated w/antibiotics. FINAL DX: Fever, resolved; viral syndrome.
extreme nausea; fatigue; Repeated vomiting beginning at approximately the 25th hour and continuing for the next several hours / was unable to keep food or liquid down for another approximate 24 hours thereafter.; Sharp pain in toes began within hours of first injection; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 18Mar2021 at 15:30 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Patient was not pregnant. Medical history included asthma and hypertension. The patient had no known allergies to medications, food or other products. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included acetylsalicylic acid (ASPIRIN), montelukast sodium (SINGULAIR) and hydrochlorothiazide (MANUFACTURER UNKNOWN); all for unknown indication from an unknown date and unknown if ongoing. On 18Mar2021, the patient experienced sharp pain in toes began within hours of first injection. On 19Mar2021 at 16:30 (as reported), approximately 22hours from first injection the patient experienced extreme nausea and fatigue, followed by repeated vomiting beginning at approximately the 25th hour and continuing for the next several hours. The patient was unable to keep food or liquid down for another approximate 24 hours thereafter. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included treatment with ondansetron (MANUFACTURER UNKNOWN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sharp pain in toes, nausea, fatigue and vomiting were recovered on unknown date in 2021. The patient also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 08Apr2021 at 15:30 (at the age of 53-years-old) as a single dose for COVID-19 immunisation.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow up report is being submitted to amend previously reported information: added Vaccination Facility information, revised narrative to add "patient was not pregnant", removed dose 2 from suspect dose regimen.
Information has been received from a 35 year old female patient with no pregnancy concerning herself. The patient had no medical history and drug reactions /allergies. On an unknown date in November 2012 and another unknown date in December 2012, the patient was vaccinated with her first and second doses of VARIVAX (Merck) (dose, strength, lot # and route were not reported), respectively. No concomitant therapies were reported. On an unknown date, the physician confirmed the patient was immune to chickenpox. On an unknown date in 2015 (reported as "recently"), the physician tested the patient again and confirmed that she was no longer immune to chickenpox. No treatment was given for the event. Unspecified blood test was performed. The patient did not seek medical attention. The outcome of the event was not reported. Additional information has been requested.
On 4/6/2021, one week after first vaccine with Moderna, extreme skin sensitivity developed (without a rash) on upper left leg, near groin. About a week later, 4/12/2021, a rash of raised, red bumps appeared at site of skin sensitivity. It was diagnosed as shingles by NP on 4/13/2021. A 7-day course of antiviral medication was prescribed. After a week of medication, the rash lessened and skin sensitivity stopped.
Pt presented with fever, cough, fatigue. Was given remdesivir and steroids and was given NC and supp O2.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 23-Jan-2021, PAIN IN EXTREMITY (sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter. Treatment for the event included acetaminophen.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Follow-up received on 15-Apr-2021 included no new information.