chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial and follow-up information has been received from two registered nurses for the pregnancy registry for GARDASIL and the initial pregnancy questionnaire, concerning a 22 year old female with penicillin allergy who on 21-JUL-2008 was vaccinated with the first dose of GARDASIL, Lot # 660553/0070X.  On 18-SEP-2008, the patient was vaccinated with the second dose of GARDASIL, Lot # 660616/0570X.  Concomitant therapy included EFEXOR, prenatal vitamins and MACROBID.  The patient was pregnant.  The patient's LMP was on 20-AUG-2008 and EED on 27-MAY-2009.  In follow-up information was reported that the estimated conception date was 26-AUG-2008.  Unspecified routine OB labs were normal.  On 13-OCT-2008 ultrasound was performed because the patient was bleeding and it showed results within normal limits.  It was reported that the patient had no previous pregnancies.  Additional information has been requested.
03/17: Head ache 03/18: Left-side body ache; overall bad; chilled; no fever
I was at work my voice was gone and I thought I had laryngitis. Then, I went home and took a COVID-19 test and it was negative 10/26/2020. The next day I went to my doctor's office, and I took a PCR test and rapid flu test, and they came back negative 10/27/2022. By this time, I was sick I had a bad headache, stuffy and running nose, laryngitis, no appetite, extreme body and joint aches, fatigue but couldn't sleep and low-grade fever of 99. I took another test the next day and I was positive for COVID-19 test. After I tested positive my symptoms started to get worse and fever went up to 101. When I talked to my doctor, we were discussing PAXLOVID, but I got the bebtelovimab monoclonal antibodies at the ER instead. I got better after 24 hours, but I start having trouble breathing 11/06/2022. I went to go see my doctor on the 8th and she listened to my lungs which didn't sound good. She did a lung X-ray and everything was clear but she said if I didn't get the monoclonal antibodies I would have been in the hospital. I am still tired and sometimes have shortness of breath.
Day of Vaccine:  Slightly blurry distance vision, mild fever, chills, mild headache, injection site pain/soreness,  One day after Vaccine: Mild fever, chills, injection site pain/soreness, red/raw tongue.  Two days after Vaccine: Mild injection site soreness, red/raw tongue.
Case number PHEH2016US024326, is an initial spontaneous report received from pharmacist on 21 Sep 2016. This case also contains QA reference number: 1016946). This report refers to a 71 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with first dose of FLUVIRIN (batch number: 168701, expiry date: Apr 2017) (patient was supposed to received 0.5 ml), into right arm, intramuscularly on 20 Sep 2016 at 14:15 pm. It was reported that, the pharmacist injected the vaccine and the solution was not fully injected into the patient and leaked out of the syringe where the needle attaches on 20 Sep 2016 at 14:15 pm. Pharmacists states the needle was firmly attached to the syringe. Partial dose was administered to the patient. No adverse event was reported following this medication error. Follow up report received from a pharmacist on 12 Oct 2016: Added patient demographics (patient initial, date of birth and gender), suspect product information (vaccination date and time, dose, route of administration and vaccination site) and updated reporter information. Following an internal review done for the data received on 22 Oct 2016, the case PHEH2016US025678 was found to be a duplicate of case PHEN2016US024326. Hence, all the information from the case PHEH2016US025678 has been merged into the case PHEN2016US024326, and the case PHEH2016US025678 has been deactivated. The reporter was updated and seriousness of the events was updated as non serious.
dizzines 5/10 min p/inject; last dose 1986; hx of dizziness & anemia;
PATIENT HAD HER SECOND HPV VACCINE (GARDASIL) AND DEVELOPED PAIN AND SWELLING IN THE LEFT SIDE OF HER NECK, AND NASAL AND SINUS CONGESTON ON THE LEFT SIDE (SHOT GIVEN IN LEFT DELTOID).  SYMPTOMS BEGAN 24 HOURS AFTER VACCINE WAS GIVEN.  SHE HAD IDENTICAL SYMPTOMS BEGINNING 36 HOURS AFTER HER INITIAL GARDASIL SHOT, AND WE CONSIDERED ADVERSE REACTION BUT SINCE IT WAS A STRANGE SET OF SYMPTOMS WE TREATED IT AS AN UPPER RESPIRATORY/SINUS CONDITION AND IT RESOLVED. HOWEVER, SINCE IT RECURRED WITH HER SECOND VACCINE DOSE, IT MUST BE RELATED TO THE VACCINE. SHE IS FINE NOW.
3 days p/vax pt devel an inj site rxn  characterized by a 2-inch area of redness, swelling, & hardness @ site of vax;tx w/hot & cold compresses, DPH & advil;
Information has been received from a nurse referring to a 14 year old male patient. The patient had drug reactions/allergies to amoxicillin. The patient had no concomitant medication or pertinent medical history. The patient completed a two-dose series of (Oka/Merck) VARIVAX subcutaneously for varicella vaccination; his first dose of (Oka/Merck) VARIVAX (lot #640073/11146L, exp 14-FEB-2003) was administered in his right arm on 13-MAR-2002 at age 12 months old; his second dose of (Oka/Merck) VARIVAX (lot# was reported as 1781A, exp 11-DEC-2010) was administered in his left arm on 24-MAR-2009 at age 8 years old. Patient developed a vesicular rash on his left mid-flank axillary area an unspecified number of days prior to visiting an urgent care clinic on 07-JUN-2015. Patient was referred to his primary physician, who suspected either impetigo or shingles, so treatment was initiated with topical mupirocin and oral acyclovir. On an unknown date of June 2015, the physician scraped a sample of a vesicle and sent it for varicella-zoster virus "antigen direct fluorescent antibody stain (AG DFA)" testing, which came back positive, confirming a diagnosis of shingles. Treatment with both mupirocin and acyclovir was continued to prevent further bacterial infection of the rash. The outcome of the event was not recovered. Additional information has been requested.
pt states after about 4 hours after taking vax she developed a headache.  She says the headache keeps getting worse and worse.  She took Tylenol and went to bed.  the next day the headache was so severe the next day that she could hardly function.  she tried to flush out the vax by drinking lots of water and not eating any food.   She took Tylenol and slept most of the next 36 hours.  After 3 days she still has a headache but started eating again.  Today she is feeling drained and still has a headache.
Pt received initial dose on 1/5/21, diagnosed with COVID-19 on 1/8/21, treated with monoclonal antibodies on 1/13/21. Pt experienced CHF exacerbation, anasarca, and renal failure during acute illness. Pt also treated for pneumonia during this time. Pt was considered terminal status on 1/25/21. She received second COVID-19 vaccine on 2/15/21. Pt then experienced increased difficulty eating and taking medications this same day, in addition to hallucinations she was experiencing. Patient subsequently died on 2/16/21.
Redness, warmth, and tenderness to the L) posterior arm, as per the patient in message and photograph to clinic. Unknown start time. Recommended cold compress to the area for discomfort and to be evaluated if the area or discomfort increased.
09/28/2021 Tuesday/ Wednesday I woke up super sick with a headache, cold, fatigue, dizziness and sore arm. It lasted about 3 days after the vaccination.
patient's mom is saying the inject site is red and swollen and hot to the touch. she states there is a perfect red circle around where the needle was put in.
12/9 woke up to Rt. ear deafness, dizziness, ringing in ear - numbness to Rt side of head and face, loss of balance, Rt. eye twitching and Rt side of head pressure went to PMD on 12/9. Then to ENT - 12/10 - put on po prednisone 40 mg. Hearing test 3/4 loss of hearing. On 12/12 received steroids by injection thru eardrum. Hearing test. Hearing declined further and increased pressure.
parent relates p/vax child seemed to have difficulty w/immune system;feels immune system may have been stressed by shot;missed a # of school days very tired;
Father phoned clinic on 10DEC91 c/o pt having temp of 103 this AM; 16JAN92 talking w/mom who finally returned response, PHN found that client had been dx w/tonsilitis on 10DEC91;
No adverse event.; a patient was administered improperly stored PROQUAD; This spontaneous report was received from a medical assistant refers to a 13-month-old patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 23-SEP-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # S012040, expiration date 17-APR-2021 (exact dose, route of administration,  lot # and expiration date were not reported)  for prophylaxis. The sterile diluent was used to reconstitute the  varicella virus vaccine live (oka/merck)(VARIVAX) The outcome of product storage error and no adverse event was unknown. Administered dose of vaccine experienced the temperature excursion of 5 to 46 degrees Fahrenheit for 6 hours and 15 minutes. Data logger was not involved. There were no previous excursions reported
Angioedema, urticaria, treatment - solumedrol 125mg IV,benadryl 25mg IV, Zantac 5u IV.
Cold-like symptoms; Runny nose; A little bit of a scratchy, itchy throat; Cough; A little bit of soreness; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold-like symptoms), RHINORRHOEA (Runny nose), THROAT IRRITATION (A little bit of a scratchy, itchy throat), COUGH (Cough) and PAIN (A little bit of soreness) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PAIN (A little bit of soreness). On 15-Mar-2021, the patient experienced COUGH (Cough). On an unknown date, the patient experienced NASOPHARYNGITIS (Cold-like symptoms), RHINORRHOEA (Runny nose) and THROAT IRRITATION (A little bit of a scratchy, itchy throat). At the time of the report, NASOPHARYNGITIS (Cold-like symptoms), RHINORRHOEA (Runny nose) and THROAT IRRITATION (A little bit of a scratchy, itchy throat) outcome was unknown, COUGH (Cough) had not resolved and PAIN (A little bit of soreness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment details not provided.  The patient had experienced a little bit of a scratchy, itchy throat, then drainage and then it developed into a cough.
10/05/2005 15:05 patient became lightheaded, pallor, diaphoretic, nauseated, and had headache. Vasovagal symptoms treated with cool compresses, water and elevated feet. Benadryl 25mg PO given per DR. Vitals at beginning BP 98/60 P60, T096.4. After patient feeling better vitals BO 100/62 P68. T 96.5. Pt then went home feeling fatigue. On 10/06/2005 Pt voiced she developed a rash on 10/05/05 in the evening. Rash present under arms and in between legs. Rash slightly raised and pink. Pt stated it felt raw. Rash treated with cortisone cream. Duration of rash was approximately 72 hours.
Myalgia, Fever, Chills, Insomnia, Injection site pain and swelling Narrative:  Noted injection site pain and swelling x 72 hours following 1st dose on 12/31/21. Received 2nd dose on 1/26/21. Pre-medicated with a dose of acetaminophen. Awoke the next day with fever, chills, myalgia and insomnia. Also felt "foggy" with difficulty concentrating. Missed work x 1 day. Symptoms improved by 1/28/21. No known prior COVID infection.  Other Relevant History:
Information has been received from a nurse practitioner referring to 4 unspecified patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates, each patient was vaccinated with a dose of improperly stored VARIVAX (dose and route were unknown; lot # M003440, expiry date: 20-JAN-2018). Data logger was involved. The doses of vaccine were improperly stored at the temperature above 14 Fahrenheit (F) but below 46 F for 9 months. There was no previous temperature excursion. No adverse effects reported. No product quality complaint (PQC) was involved. Additional information has been requested.
On 9/10/2021 patient came to the pharmacy seeking her flu shot. Flu shot was prepared for the patient. The vaccine administrator called out a different patients name to which the patient responded and confirmed she was the other patient verbally. When asked if she was here for her second dose of pfizer covid vaccine she again responded yes. The patient received the pfizer vaccine that was intended for a different patient. The incident was discovered when the intended patient asked on the status of her vaccine.
Pain and stiffness in arm and fever originally but since have been diagnosed with fibromyalgia. Headache that now have become chronic migraines. Fatigue that has now been diagnosed as idiopathic hypersomnia/borderline narcolepsy.
Sudden stinging, burning, itching, red hives/small bump cluster flare up inner thighs. Time course around 4/17/16 to around 4/28/16. Treatment cold compress, Caladryl clear lotion, diaper rash ointment, A&D ointment, and Claritin D.
EXPERIENCED HEADACHE, WARM, LEGS SORE STARTED AT 2 PM  ON 12/20/21AND LASTED UNTIL THE NEXT MORNING 12/21/21
developed two boils after getting the first dose of the COVID-19 vaccine; This is a spontaneous report from a contactable consumer.  A female patient of an unspecified age received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL1284), via an unspecified route of administration in the left upper arm on 29Dec2020 at 12:00 at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient developed two boils after getting the first dose of the COVID-19 vaccine (non-serious) on 29Dec2020. The patient said she had received her first dose of the COVID-19 Vaccine on 29Dec2020 at 12:00 in her left upper arm. The patient said she had developed boils since she received the COVID-19 vaccine. The patient said that she had never had boils, and now she had two boils. Therapeutic measures were taken as a result of the boils, which included antibiotics. The clinical outcome of the event was unknown.
Slept. Almost all day; started to sweat; left arm started to get sore; left arm injection site has got this big red welts where they injected the Vaccine; This spontaneous case was reported by a patient and describes the occurrence of HYPERSOMNIA (Slept. Almost all day), HYPERHIDROSIS (started to sweat), VACCINATION SITE URTICARIA (left arm injection site has got this big red welts where they injected the Vaccine) and PAIN IN EXTREMITY (left arm started to get sore) in a 75-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031488) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna Primary monovalent (Shot 1: First Moderna Primary monovalent dose) in 2021, Moderna Primary monovalent (Shot 2: 2nd Moderna Primary monovalent dose) in 2021 and First Moderna Monovalent Booster dose (Shot 3: First Moderna Monovalent Booster dose) in 2022; for Product used for unknown indication: Pfizer (Shot 4: Pfizer) in 2022. Past adverse reactions to the above products included No adverse event with First Moderna Monovalent Booster dose, Moderna Primary monovalent, Moderna Primary monovalent and Pfizer.    On 10-Nov-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 10-Nov-2023, the patient experienced HYPERHIDROSIS (started to sweat) and PAIN IN EXTREMITY (left arm started to get sore). On 11-Nov-2023, the patient experienced HYPERSOMNIA (Slept. Almost all day). In November 2023, the patient experienced VACCINATION SITE URTICARIA (left arm injection site has got this big red welts where they injected the Vaccine). On 12-Nov-2023, HYPERSOMNIA (Slept. Almost all day) had resolved. In November 2023, HYPERHIDROSIS (started to sweat) and PAIN IN EXTREMITY (left arm started to get sore) had resolved. At the time of the report, VACCINATION SITE URTICARIA (left arm injection site has got this big red welts where they injected the Vaccine) had not resolved.            No concomitant medications were reported.  Reported that on 10-Nov-2023, his left arm started to get sore and he started to sweat, Slept. Almost all-day Saturday. On Sunday, 12-Nov-2023, he got up and felt a lot better. He feels okay now, except his left arm injection site has got this big red welts where they injected the Vaccine.  No treatment medications were reported.  Company Comment: This is a Spontaneous case reported by a patient, concerning a 75-year-old male patient, with no medical history reported, who experienced the unexpected and non-serious AESI of Hypersomnia, which occurred the same day after SPIKEVAX 2023-2024 vaccine, administered as fifth dose within COVID-19 vaccination schedule. As reported, the patient slept almost all-day after vaccination. No information disclosed about diagnostic tests performed or treatments received. The event resolved after 1 day. The benefit-risk relationship of SPIKEVAX 2023-2024 vaccine is not affected by this report.
24 hours after injection developed extreme case of hives all over, horrible itching; horrible itching; This is a spontaneous report from a contactable other HCP.   A 72 year non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, via an intramuscular at Arm Left on 04Feb2021 (Lot Number: EJ3002; Expiration Date: 01Apr2021) second dose via an unspecified route of administration at Left arm on 24Feb2021 07:30 PM (Lot Number and expiry date unknown) as a single dose for covid-19 immunisation. On 05Feb20 patient had other vaccine 4weeks prior to the vaccine product was Tetanus unspecified route at left arm of administration. Medical history was included IBS, HYPOTHYROIDISM, ADD. Concomitant medications were included two weeks Arm our thyroid, losartan, norvasc, ADDERALL. Patient had allergies the drug of Codeine. On 25Febs2021 08:00 PM 24 hours after injection developed extreme case of hives all over, horrible itching, saw doctor who treated with Decatron injection, oral prednisone taper, Pepcid, prednisone cream yesterday and then today when the hives and itching was even worse given iv decatron and prescribed vistaril in addition to continuing other meds still intense itching and breaking out in more places. The outcome of the events as not recovered.  No follow-up attempts are Possible. Information on lot/batch cannot be obtained.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events urticaria and pruritus and the suspect drug.  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.
Initial information received on 30-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 5 years old patient who received GARDASIL instead of PENTACEL, while he/she received vaccines GARDASIL and PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient did not receive a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number not reported via unknown route but received a dose of suspect GARDASIL not produced by Sanofi Pasteur lot number not reported via unknown route. It was a case of potential medication error due to wrong vaccine administered. (Other relevant tests included No lab test). Final diagnosis was patient received GARDASIL instead of PENTACEL. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Not Applicable for patient received GARDASIL instead of PENTACEL. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 11-JAN-2017, the patient was vaccinated with an improperly stored dose of PROQUAD, lot number L040415, expiration date 13-APR-2017 (dose, route and anatomical location were not reported) for prophylaxis (incorrect product storage). The vaccine was exposed to temperature of -5 Fahrenheit (F) (-20 Celsius(C)) and to the lowest recorded temperature of -14 F (-25C) during 4 hours and 5 minutes. The storage type was reported as "data logger". There was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1701USA012890: US-009507513-1701USA013083: US-009507513-1701USA013084: US-009507513-1701USA013085: US-009507513-1701USA013086: US-009507513-1701USA013087: US-009507513-1701USA013088: US-009507513-1701USA013089: US-009507513-1701USA013090: US-009507513-1701USA013092: US-009507513-1701USA013093: US-009507513-1701USA013094: US-009507513-1701USA013095: US-009507513-1701USA013096: US-009507513-1701USA013097: US-009507513-1701USA013098: US-009507513-1701USA013099: US-009507513-1701USA013100: US-009507513-1701USA013101: US-009507513-1701USA013102: US-009507513-1701USA013103: US-009507513-1701USA013104: US-009507513-1701USA013105: US-009507513-1701USA013106: US-009507513-1701USA013107: US-009507513-1701USA013108: US-009507513-1701USA013109: US-009507513-1701USA013110: US-009507513-1701USA013082:
Patient's arm turned red, swollen, itchy. Came back to pharmacy next day, purchased Benadryl topical and systemic to use.
The next night after receiving vaccination I began to feel body aches with a low grade fever. My baby who was breastfeeding spiked a low grade temp as well. The following day I continued with body aches, low grade temp, headache and I was very lightheaded almost in a "fog" type state to the point I did not feel comfortable to even drive. I had taken no medication until 12/24/2020. I took one dose of I believe Tylenol and the low grade temp and body aches subsided. I did continue with headaches for the next couple days that would come and go. When the pain came on it would come on quickly and then subside. A few days after holiday I tested positive for covid-19.
approx 1 hr p/vax began w/shaking then SOB; treated w/APAP & DPH & Adrenalin;
-PALENESS                  1120-B/P-79/40-79-PULSE 02-99 HYPOTENSION         1125-B/P 89/48-73-02-99-SAT COLD,CLAMMY SKIN11:30-99/69-63-02-99-SAT LIGHT-HEADNESS          11:45-106/76-62-99-SAT
Redness, itching and rough skin at injection site. Injection site was a hard lump. Unknown when started, per patient was improving on Monday. Used ice pack to decrease reaction.