chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1.  Sore arm started several hours later approximately 9 PM 12/29/2020 2.  Chills started approximately 12:30 AM on the following day 12/30/2020 3.  Severe myalgias and arthralgias with difficulty moving approximately 6 AM 12/30/2020 4.  Fever starting approximately 6 AM starting 101.5-1 03 then later in  the day 105. 5.  Severe headache starting approximately 9 AM 12/30/2020 and persists but much less 6.  Nausea starting approximately 9 AM 12/30/2020
recurrent spot, Herpes Zoster or Herpes Simplex Virus; This case was reported by a consumer via call center representative and described the occurrence of vesicular rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included herpes zoster.   On 16th November 2022, the patient received the 1st dose of Shingrix. In November 2022, less than 2 weeks after receiving Shingrix, the patient experienced vesicular rash. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the vesicular rash was not recovered/not resolved.   It was unknown if the reporter considered the vesicular rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 28-Nov-2022. Reporter's Comment:  The reporter was the patient, who stated that she received her Shingrix. The patient stated that she had a recurrent spot on her back which her doctor does not know if it was due to Herpes Zoster or Herpes Simplex Virus.  The patient said that the spot had appeared on and off for the past 33 years.  The patient was recently prescribed Valtrex to treat the spot. The reporter did not consent to follow-up.
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 33-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The RX number was 802112.  No concomitant medication was provided by the reporter.  No treatment medication was provided by the reporter.  The Pharmacist reported administration of an expired  Moderna vaccine to patients of around 490 to 500 people on the date last Oct 20,2021 to Nov 29,2021. Dose administered after 30-day Use By Date or after manufacturer date of expiry.  Reporter has provided lot Number of vaccine as follows: 006C21A (10-10-2021), 026B21A (09-17-2021), and 031B21A (9-22-2021).  Reporter stated that vaccines were stored in freezer and used one to two vials each day as needed, placed in fridge.~
Sudden onset chills/fever/achiness Temp 102.8 degrees and vomiting, several times.
Received DT afternoon of 8/26/03. Patient presented to ER 21:15 8/26/03 with hives and tight feeling in throat. Received IM Benadryl and SQ Epinephrine.
This spontaneous report was received from an office manager concerning an unknown number of patients of unknown ages and genders. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with doses of RECOMBIVAX HB, for prophylaxis (dose number, route and anatomical location of administration, lot number and expiration date were not reported). The doses were stored between 32 to 35 Fahrenheit degrees for 120 hours, and 31 Fahrenheit degrees for 216 hours. There was no previous temperature excursion nor data logger involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA004094: US-009507513-1705USA004191: US-009507513-1705USA004192: US-009507513-1705USA004193: US-009507513-1705USA004194.
This spontaneous report was received from a licensed practical Nurse referring to a 76 year old female patient. The patient's concurrent conditions included post-menopausal, thyroid nodular and immunoglobulin A deficiency and the patient's drug reactions or allergies included penicillin, information regarding the patient's medical history was not provided. On 10-OCT-2016, the patient was vaccinated with PNEUMOVAX 23 dose number 1, via intramuscular in the right deltoid (lot number, expiration date and dose were not reported).Concomitant therapies included Lisinopril (manufacturer unknown), atenolol and potassium. On 12-OCT-2016, the patient experienced pain at injection site, radiating to right arm pit and developed 3 red blotches and the largest one measured 7.5 cm, all on right deltoid. Additionally, it was also reported that the patient contacted physician (unspecified if required office visit), who recommended using warm compresses and BENADRYL as needed. No laboratories were performed and a product quality complaint was not involved. The patient recovered from the events on an unspecified date in October 2016. The causality between PNEUMOVAX 23 and the adverse events was not reported. Additional information has been requested.
Chills, fever, headache, mild nausea, severe body aches & pains
Information has been received from a consumer concerning herself who in approximately 2005 ("2005 or 2006"), was vaccinated with GARDASIL. The patient completed dosing schedule (lot number not provided). On an unspecified date, the patient was diagnosed as having Human Papilloma Virus (HPV) despite completing the dosing schedule. At the time of reporting, the patient was not recovered. The patient sought unspecified medical attention. Follow up information has been received from a physician concerning the 29 year old female patient with a history of Crohn's Disease, significant inflammatory bowel disease and anaphylaxis reaction to REMICADE and with no illness at time of vaccination who on 01-NOV-2006, 17-JAN-2007 and 30-MAY-2007 were vaccinated IM with the first, second and third doses of GARDASIL. She was currently receiving immunosuppressant medication. On 19-MAY-2010 the patient underwent PAP smear (LMP 30-APR-2010) with satisfactory for evaluation. Endocervical component was present. HSIL encompassing: moderate and severe dysplasia, carcinoma in situ; CIN 2 and CIN 3. On 15-JUN-2010 ciproscopy and PAP smear revealed the patient had uterine cervix at 4 o'clock and 10 o'clock with CIN 1, at 2 o'clock with no significant histopathologic abnormality. On 21-JUL-2010 genotype testing indicated that she was positive for HPV 16 and negative for HPV 18. On 28-AUG-2010 the patient underwent Loop Electrosurgical Excision Procedure (LEEP). Pathology report indicated that the patient had transformation zone with CIN 1, no evidence of invasion and the dysplasia extended to the ectocervical margin. Post LEEP procedure the patient was instructed to remain on bedrest for 3 weeks and to call with any concerns. On 13-SEP-2010 the patient recovered. Additional information is not expected.
Pt complains of feeling weak, difficulty breathing and fast heart rate. Talked with wife, told her to take patient to ER with Immunization record.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 15-MAY-2014 the patient was vaccinated with (Oka/Merck) VARIVAX, subcutaneous (dose, frequency, lot # not reported) which temperature fell outside the temperature parameters in the prescribing information, but was supported by in house stability data. There was no adverse effects and PQC reported. Additional information has been requested.
Employee received vaccine, c/o shortness of breath, throat tightness, difficulty swallowing, difficulty breathing and hoarseness.  METS team called and Employee taken to Emergency Room.
temperature went up to 99; Feeling dragged out; This is a spontaneous report from a contactable consumer.   A 72-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,Lot number: not reported), dose 1 intramuscular, administered in Arm Left on 22Jan2021 at single dose for covid-19 immunisation.  Medical history included ongoing atrial fibrillation diagnosed about 5 years ago. None Prior Vaccinations within 4 weeks. AE(s) following prior vaccinations: Sore arm with flu shot that she got in Sep2020, she does not know the name or have lot number to provide. Concomitant medication(s) included apixaban, 5mg tablet twice a day by mouth (ELIQUIS) metoprolol, 25mg tablet, half tablet once a day by mouth (METOPROLOL) and flecainide, 50mg, one tablet every twelve hours by mouth taken for atrial fibrillation. The patient experienced feeling dragged out on 24Jan2021, temperature went up to 99. The patient underwent lab tests and procedures which included body temperature: around 97 or 98 on, body temperature: up to 99 on 26Jan2021 little bit of temperature hike/usually temperature was around 97 or 98 and her temperature went up to 99. Additional Context included She was calling about the Pfizer first dose of covid shot. She was asking when you get a reaction from the shot, is it immediate or it does it take a while to have a reaction. She clarifies it is the Pfizer sars-cov2 vaccine. Her second dose was scheduled for 12Feb2021. She clarifies that she was not know if she has a sinus infection or a reaction to the shot since the symptoms are similar. She was felt dragged out for a couple of days, today she was feeling a little bit better but not 100%. She got the first dose on Friday afternoon and she did not have any problems right after receiving it. She had to wait there for 15 minutes after receiving the shot. Reports she started feeling dragged out Sunday night but it was not that bad and it started getting bad Monday afternoon, Yesterday was bad, and today she was a tiny bit better, but still feels dragged out. She had a little bit of temperature hike but nothing major, her usually temperature was around 97 or 98 and her temperature went up to 99 yesterday. The outcome of the event(Feeling abnormal) was recovering and event (Body temperature abnormal) was recovered on 27Jan2021.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Swelling from hip to knee. Red also. Resolved w/in 48 hrs.
Pregnancy; Initial Report Received on 28-Jun-2022 (Central Receipt Date: 01-Sep-2022)  A pregnant patient reported to the pregnancy registry that she, a 25-year-old patient (race and ethnicity not provided) with estimated due date of 05-Nov-2022, received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On 28-Jun-2022, the patient received a dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported) with route and site not reported from the pharmacy.   The pharmacy did not have the patient listed as pregnant in their charts. It is her first pregnancy.   The call was lost before the patient could provide her obstetrician contact information and confirm participation and consent to the pregnancy registry.   No additional information was reported. Consent for additional follow-up with the patient was not granted.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
The pt developed redness, and swelling at the injection site (right arm). Treated with Benadryl in ER. On 05/03/2002, saw PMD with warm, red, covered entire upper arm to shoulder 1cm below elbow.
Patient returned to pharmacy on 8/28/2017 to report redness and swelling the left arm; redness covered entire upper arm area.  Patient reports that he noticed the reaction the night before (8/27/2017).
Rash, fatigue, runny nose, high blood pressure, body aches, subconjuctival hemorrhage, headache, neck stiffness, nausea
Very painful, swollen, hard "knot" (2" dia, raised about 1"), bright red itchy rash (3" diameter) around injection site; remained this way until 03/13/2021 when it started to fade and swelling went down substantially. Took Benadryl for itching.  Ran fever between 100 and 100.4 for one day only (03/11/2021). 03/14/2021 - still have a slight bump and is tender to touch, rash is still visible but fading. Note: This was the second Moderna vaccine.  For the first one on 02/10/2021, the only reaction I had was a slightly sore arm at the injection site the first day after the shot.
Fussiness, swelling, fever of 102, swelling at injection site LVL.
Initial report received on 09 May 2011 from the Investigator participating in a post-marketing observational surveillance study. This is one case out of a cumulative total of 19 pertussis cases received during the surveillance period between 01 January 2010 and 09 May 2011. A case of pertussis disease in a 12 month old, male subject (initials not collected) was identified by the Investigator based on review of data from the Electronic Disease Surveillance System. The subject's vaccine history included 3 doses of PENTACEL vaccine: dose 3 was received on 02 September 2010, dose 2 was received on 01 June 2010, and dose 1 was received on 30 March 2010 (lot numbers, route and site of administration were not reported). The subject developed cold-like symptoms on 11 February 2011, approximately 162 days after his last dose of PENTACEL. In addition, the subject developed a paroxysmal cough with a whoop. Laboratory testing included positive PCR (date not reported). Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 25 March 2011 for 5 days. The subject was not hospitalized. At the time of final contact on 31 March 2011, the subject's cough was still persisting. The duration of the cough was reported at that time as 78 days. The outcome was not reported. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
small red spots on my skin; lips swollen; all my body was red; all my body was itchy; skin allergies or allergic reaction; Hives; I was feeling bad; All my body was in pain; Headaches; This spontaneous case was reported by a medical assistant (subsequently medically confirmed) and describes the occurrence of URTICARIA (Hives), RASH MACULAR (small red spots on my skin), LIP SWELLING (lips swollen), ERYTHEMA (all my body was red) and PRURITUS (all my body was itchy) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: HPV VACCINE VLP RL1 9V (YEAST) (HPV-9 vaccine manufacture is Gardasil 9 and given Intramuscular and dose is 3 of 3.) on 03-Dec-2020. Concurrent medical conditions included Hyperthyroidism and Drug allergy (Methimazole). Concomitant products included LEVOTHYROXINE and NORETHINDRONE [NORETHISTERONE] for an unknown indication.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Jan-2021, the patient experienced MYALGIA (All my body was in pain) and HEADACHE (Headaches). On 21-Jan-2021, the patient experienced FEELING ABNORMAL (I was feeling bad). On 22-Jan-2021, the patient experienced URTICARIA (Hives). On an unknown date, the patient experienced RASH MACULAR (small red spots on my skin), LIP SWELLING (lips swollen), ERYTHEMA (all my body was red) and PRURITUS (all my body was itchy). At the time of the report, URTICARIA (Hives), RASH MACULAR (small red spots on my skin), LIP SWELLING (lips swollen), ERYTHEMA (all my body was red), PRURITUS (all my body was itchy), MYALGIA (All my body was in pain) and HEADACHE (Headaches) had not resolved and FEELING ABNORMAL (I was feeling bad) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, White blood cell count: 14.3 (High) 14.3 K/ul.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications are Medrol 4 mg oral, and stopped on 09 Feb 2021 and after consulting her PCP, the PCP doctor told patient to stop using that medication and start using Prednisone 10 mg. Dermatologist recommended Thamanolone for allergies.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Insignificant follow up received contains NNI.
Information was rec'd concerning a pt with seasonal allergies who on 9/10/01 in the PM and on 10/10/01 in the PM was vaccinated with the 1st (lot#636717/1592K) and 2nd (635178/0473K) dose of hepatitis B vaccine recombinant, both administered in the L deltoid. Concomitant therapy included Loratadine ( Claritin). There was no illness at the time of vaccination. Subsequently, after each dose the  pt developed itching at the injection site, described by the pt as occurring "inside the site". It was reported that the itching lasted 2 to 3 days and the pt recovered. It was noted that the pt opted "not to receive the 3rd vaccine". No further information is expected.
after vaccination, pt became extremely diaphoretic and dizzy. placed on floor with legs elevated, no LOC,  BP 90/50 at 12:35pm ice pack applied to back of neck, fluids given.  BP 110/60 after intervention.  pt felt better and left clinic without needing help.
This spontaneous report was received from a pharmacist refers to a female patient of unknown age. The patient was vaccinated with a dose of PNEUMOVAX 23, (lot number was reported as 0595AA, expiration date 30-AUG-2012) on 26-SEP-2012). Concomitant medications were not reported. No adverse event was reported. this is one of the reports received from the same reporter. Additional information has been requested.
Initial misuse report received from a healthcare professional on 24 September 2013. The cases were received on 21 March 2014. A patient had received a dose of PENTACEL on an unspecified date. It was reported that the patient received only the Dtap/IPV and did not give the ActHib powder. No adverse events were reported. List of documents held by sender: none
On the first day shortly mild pain in left arm around 08:00pm exp brief pain in chest  that occurred twice and went to bed. I woke up on 12/16 after resting on right side and tried to rollover upon waking up was in excruciating pain. arm around 5am  woke up for work couldn't move my arm, barely could dress to put my shirt on on a scale 1-10 rate 7. As a result it was hard to due my daily activities or hygiene. The following day 12/17 pain felt mild and on 12/18 felt no more pain.
"I had PNEUMOVAX 2 years ago when I was diagnosed with asthma." He had pneumonia on 3/4/2015. "At the end of March 2015, they gave me PREVNAR 13."
Information has been received from a physician concerning a 25 year old female who, about 5 years ago, in approximately 2000, was vaccinated with a dose of varicella virus vaccine live.  It was reported that a varicella titer was drawn on 01/19/2005 and failed to detect seroconversion.  It was noted that the patient has no symptoms.  Unspecified medical attention was sought.  No product quality complaint was involved.  No other information was provided.  Additional information has been requested.
I had previously had the Covid virus in October 2020. After taking the first vaccine, I woke up at three in the morning with symptoms as if I had Covid all over again. Most notably was the fever of 102°F, horrible random pains, headache and elevated blood pressure. Somewhere between 8 to 10 in the morning that same day I developed much higher than normal blood pressure and profuse nose bleeding. When I had Covid prior I did not experience nosebleeds. I also have not historically had a problem with nosebleeds and certainly not the gushing and difficult to stop nose bleeds that came after the Covid vaccine. The high blood pressure and nose bleeds lasted for 18 days and then tapered off with a couple of very short-lived nose bleeds over the next 2 to 3 days. The nosebleeds were so concerning because of the large amount of blood loss. I ended up getting blood work done at my primary care physicians office on 11 June 2021. My doctor ordered a CBC with differential, Protime-INR and APTT. You could probably get the results from these tests from my primary care doctor. I also reported all of the symptoms he dictated in my chart all of it.
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient had gotten her two dose series with SHINGRIX and the healthcare professional said the patient had a sore arm after each injection, but the soreness seemed to be more pronounced after the 2nd dose. These symptoms only lasted a few days. For tolerance after 2nd dose refer case US2018GSK159923.
Initial report received on 20 December 2007 from a health care professional. A 28-year-old female patient had received a left deltoid, intramuscular injection of Adacel, lot number C2889AA, on 19 December 2007. One hour post-vaccination, the patient developed a low grade temperature of 100.2 degrees Fahrenheit, general body aches, headache, dizziness, nausea, and soreness at the injection site. The patient was examined by a physician. CBC, complete metabolic panel, urinalysis, pregnancy test, and influenza testing were pending. At the time of this report, the patient had not recovered.
area around inj site red, sl swollen & 2 1/2 inches x 2 1/4 inches; warm spaces/soaks to area APAP given;
scab at the injection site; Shoulder pain; This case was reported by a consumer via call center representative and described the occurrence of injection site scab in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th December 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In December 2021, 3 days after receiving Shingrix, the patient experienced injection site scab and shoulder pain. On an unknown date, the outcome of the injection site scab was not recovered/not resolved and the outcome of the shoulder pain was unknown.   It was unknown if the reporter considered the injection site scab and shoulder pain to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received dose Shingrix vaccine into her left arm muscle and a few days after the injection experienced scab at the injection site and shoulder pain.  The scab was still there as of today(day of reporting). The reporter did not have the lot number or expiration date of the vaccine administered. The patient gave consent to contact her HCP (health care professional). The reporter consented to follow-up. GSK note- there was discrepancy in reported information. The Time to Onset was provided as 3 days in structured filed but in narrative, it is mentioned as few days after vaccination event started. TTO is captured as per structured field.