chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a 21 year old female consumer with hydrocodone allergy who on 24-MAR-2008 was vaccinated with a first dose of GARDASIL (lot # not reported). Concomitant therapy included Tdap. It was reported that the patient was approximately six weeks pregnant (estimated LMP 20-OCT-2007) when she received dose of GARDASIL. It was also reported that the patient developed a bruise at the injection and her arm was sore for several days. The patient sought unspecified medical attention. Additional information has been requested. Follow up information has been received from the patient who had no problems and delivered her baby at 39 weeks and 1 day gestation. She said the baby was healthy and normal. Additional information is not expected.
Information has been received from a physician concerning a 2 month old male, with no medical history and no allergies, who on 30-JUL-2007 was vaccinated with a 2 ml oral first dose of Rotateq. Concomitant vaccines included a dose of DTaP, a dose of IPOL, a dose of Prevnar and a dose of Comvax (MSD). Approximately 12 to 24 hours after vaccination, the patient developed several episodes of vomiting, once or twice a day since the day of vaccination. The patient was seen by a health care professional on 31-JUL-2007 for vomiting, no diarrhea was reported. The patient continued with approximately 1 vomiting episode per day. On 08-AUG-2007 the patient vomited bright red blood following a feeding with breastmilk. The patient was hospitalized for evaluation and observation. It was reported that vomiting had since resolved. Laboratory studies during the events an alanine aminotransferase test and an aspartate aminotransferase test, which increased in the "300's." It was noted that the tests had since decreased. There was no noted increased in bilirubin, GGT, or albumin levels. Pyloric stenosis was ruled out. There was no evidence of neonatal hepatitis, and results from a newborn screen and "congenital disorder screen" were not significant. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Patient completed COVID-19 vaccine series on 2/12/21. Patient was admitted to reporting hospital on 9/6/21 and discharged on 9/15/21. Patient was admitted due to confusion and severe COVID-19 with pneumonia and acute hypoxic respiratory failure. Admission test for COVID-19 was positive per PCR NP swab on 9/6/21.
Slight soreness of injection site until today.  There is a 1.5 X 2 in raised, red triangular area around the injection site.  It is warm and  painful; however, the patient says it is not getting more painful.  The actually injection point as a raised, smooth, moderately dark pink wheal about  4 X 4 mm.  No drainage at site.  The Wheal reminds me of an old smallpox  vaccine scar.
pain radiating down arm from injection site warmth at site  then itching with no rash  now itching with red rash and heat
patient received an incomplete dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 477X5, expiry date 27-MAY-2024) for prophylaxis.   On 05-MAY-2023, the patient received Shingrix. On 05-MAY-2023, an unknown time after receiving Shingrix, the patient experienced incomplete dose administered (Verbatim: patient received an incomplete dose). The outcome of the incomplete dose administered was unknown.   Additional Information: GSK receipt date: 05-MAY-2023 The reporter reported that a patient received an incomplete dose due to vaccine leaking three drops from the syringe needle.  This was not a PQC due to GSK not manufacturing the syringe. The reporter stated that 0.45 ml may have been administered but was not sure.  The reporter did not consent to follow-up. The patient received an incomplete dose due to vaccine leaking three drops from the syringe needle, which led to Incomplete dose administered.
Patient reports flu like symptoms including, muscle aches, chills, nausea. Symptoms started around 7PM the evening of the vaccination and continued for 2 days following injection.
backache, h/a, chills w/fever which fever lasted until next day till about 5PM;weakness till mid-afternoon second day then OK again;
DONOR EXPERIENCED SWEATING, RINGING IN EARS, AND TINGING IN HANDS FOR ABOUT 5 MINS AFTER RECEIVING VACCINATION.
This case was reported by a healthcare professional via other manufacturer Merck and described the occurrence of not responding to therapy in an adult male subject who was vaccinated with ENGERIX B. In October 1995, January 1996 and August 1996 the subject received 1st dose, 2nd dose and 3rd dose of ENGERIX B (unknown) and experienced drug dose administration interval too long. On an unknown date after vaccination with ENGERIX B, the subject experienced not responding to therapy. On 28 July 2009, a nurse reported that a subject received three doses of a Hepatitis B vaccine and now has a negative titer. It is unknown if it was Recombivax or another company. The vaccinations are given in October 1995, January 1996, and August 1996. On 18 August 2009, additional information was reported. The nurse stated that she investigated the subject's chart; the subject did not received Recombivax but received ENGERIX B from GSK. No additional information is available. Follow-up information received on 21 September 2009, via healthcare professional. Previous and/or concurrent vaccination included MMR vaccine (non-gsk); Merck; unknown given on 13 April 1999. On 13 October 1995, 31 January 1996 and 6 August 1996 the subject received 1st dose, 2nd dose and 3rd dose of ENGERIX B (unknown). The healthcare professional reported the subject had no adverse reaction. Laboratory test on 08 July 2009 showed no immunity.
Patient sustained a vasovagal syncope event approximately 3 to 4 minutes after their vaccination. Fell to ground sustaining abrasion to right cheek. Advised ER evaluation but patient refused. Observed for 30 minutes w/o sequelae and released at patient insistence. Spoke with patient by phone today and he notes that he feels well and has experienced no new, recurrent, or residual symptoms.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site numbness in a 86-year-old female patient who received SHINGRIX (batch number 9NJ59, expiry date 23rd July 2018) for prophylaxis. On 23rd July 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 23rd July 2018, immediately after receiving SHINGRIX, the patient experienced injection site numbness. On 23rd July 2018, the outcome of the injection site numbness was recovered/resolved. It was unknown if the reporter considered the injection site numbness to be related to SHINGRIX. Additional information was received as follows: The pharmacist reported that right after the injection the patient experienced numbness that started at the injection site and went down her arm. After 5 minutes the numbness resolved. The patient did not feel any further symptoms and did not have any swelling.
This spontaneous report as received from a physician via company representatives and from a support services director, refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 18-NOV-2015, the patient was vaccinated with a dose of improperly stored ROTATEQ "2ml, 10 unit dose tube" and lot number K009752 with expiration date of 15-APR-2016, orally, which was stored at the lowest recorded temperature of 33 (0.555555556 Celsius degrees) for 72 hours and at the lowest recorded temperature of 34 (1.111111111 Celsius degrees) for 144 hours. The storage criteria and the storage type were reported as "Refrigerator (R)". The vaccine status was reported as "in excursion". No adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Fever of 102 the following morning after receiving vaccine. The following day itchy chicken pox rash started and spread from head to toe- consistent with varicella illness.
Patient fully vaccinated (janssen) but not boosted admitted to the hospital with COVID-19 and associated hypoxia
period type Nausea feeling; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (period type Nausea feeling) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050C21A and 023C21A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid infection, Anxiety, Hypertension, Asthma and Penicillin allergy.   On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NAUSEA (period type Nausea feeling). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse reaction, at an unspecified dose and frequency. At the time of the report, NAUSEA (period type Nausea feeling) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.   This case was linked to MOD-2021-364745 (Patient Link).
12/30/20: Mild headache 12/31/20-1/2/21: Body aches, fatigue, chills, right arm pain, mild redness/swelling at injection site, mild itching around injection site 1/3/21-1/5/21: Fatigue 1/6/21: Symptoms resolve 1/7/21: Extreme itching around injection site, redness around injection site with multiple raised indurations, warm to touch, swelling, muscle ache, fatigue. Doctor seen and prescribed Doxycycline, Triamcinolone ointment, and Benadryl. Also, prescribed Prednisone in case reaction becomes more widespread. 1/8/21: Mild swelling/muscle pain to site, redness, itching persist, warm to touch 1/9/21: Swelling/muscle pain subsides, but redness and itching persist. Redness slowly spreading down arm. 1/10/21: Mild redness remains and continues to slowly spread down arm. Mild itching continues. Continuing to take Doxycycline and Benadryl PO, along with applying Triamcinolone acetonide ointment to affected area.
After receiving vaccine patient reports her head was spinning patient stated she felt like she received Morphine "I'm feeling very dizzy" her arms and legs began to shake respiratory rate increased. Pt received epinephrine and Benadryl and transported to ER via 911.
Severe Flu Symptoms Chills, Aches, Pain, Hurt all over Bones Muscles, Weakness, Sleeplessness
initially, coughing and tingling in hands. Progressed into heightened tightness in hands, face, jaw, eyes and arms.
Information has been received from a registered nurse concerning a college-age female who on unspecified dates, was vaccinated with the first, second and third doses of GARDASIL. Subsequently the patient experienced five abnormal pap smears since receiving GARDASIL. Prior to receiving GARDASIL, the patient had normal pap smears. The patient sought unspecified medical attention. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. This is one of two reports from the same source. Additional information has been requested. 07/08/2008 This is in follow-up to report(s) previously submitted on 5/14/2008. Information has been received from a registered nurse concerning a college-age female between the age of 19-21, who on unspecified dates, was vaccinated with the first, second and third doses of GARDASIL. Subsequently the patient experienced five abnormal pap smears since receiving GARDASIL. Prior to receiving GARDASIL, the patient had normal pap smears. The patient sought unspecified medical attention. It was reported that the patient underwent further testing and the results were reported as negative. No product quality complaint was involved. This is one of two reports from the same source. No further information is available.
Patient reported back to the pharmacy that her symptoms folllowing first dose of Moderna were significantly impactful and she requested a form be filled out.  Patient reported feeling achy, tired and having a HA on 4-8-21.  Slept most of day and awoke to a fever (103.4) and chills.  Patient reported feeling this way through evening hours on 4-9-21.  By 4-10-21, patient saud she was extremely lethargic and simply unable to do anything except sleep for the better part of two weeks; requiring three hour naps daily.
injection site itched/Weird; Red rash! Right underneath the injection site; Little sick; Sore Arm; Nauseous; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Sore Arm), ILLNESS (Little sick), VACCINATION SITE PRURITUS (injection site itched/Weird), VACCINATION SITE RASH (Red rash! Right underneath the injection site) and NAUSEA (Nauseous) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Food allergy (Honey), Fibromyalgia since 2003 and Pollen allergy. Concomitant products included CHLORPHENIRAMINE MALEATE from an unknown date to 10-Mar-2021 for Pollen allergy.    On 12-Mar-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced NAUSEA (Nauseous). On 12-Mar-2021 at 3:00 AM, the patient experienced PAIN IN EXTREMITY (Sore Arm). On 14-Mar-2021, the patient experienced ILLNESS (Little sick). On 16-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (injection site itched/Weird) and VACCINATION SITE RASH (Red rash! Right underneath the injection site). At the time of the report, PAIN IN EXTREMITY (Sore Arm), ILLNESS (Little sick), VACCINATION SITE PRURITUS (injection site itched/Weird), VACCINATION SITE RASH (Red rash! Right underneath the injection site) and NAUSEA (Nauseous) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-076590 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 19-Mar-2021: Patient's age, New event added. On 16-May-2021: Completed ADR received with additional AE information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-076590:Second dose case
This case was reported by a consumer via call center representative and described the occurrence of chills in a 65-year-old female patient who received SHINGRIX for prophylaxis. On 18th May 2018, the patient received the 1st dose of SHINGRIX. On 18th May 2018, less than a day after receiving SHINGRIX, the patient experienced chills and feeling unwell. On an unknown date, the outcome of the chills and feeling unwell were unknown. It was unknown if the reporter considered the chills and feeling unwell to be related to SHINGRIX. Additional details reported as follows: The patient experienced chills and had not feeling well, that began from the night of the vaccination. At the time of reporting, the patient could not locate the 2nd dose of SHINGRIX. The patient asked about that, need to get a 2nd dose. The reporter referred to her physician. The call center representative not asked about health care provider. The reporter requested to end this call, she had to go.
cold sores; sensitive gums; sore spots; This case was reported by a pharmacist via call center representative and described the occurrence of cold sores in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th April 2019, the patient received the 1st dose of Shingrix. On 14th April 2019, 2 days after receiving Shingrix, the patient experienced cold sores, sensitivity of gums and sore mouth. On an unknown date, the outcome of the cold sores, sensitivity of gums and sore mouth were unknown.   It was unknown if the reporter considered the cold sores, sensitivity of gums and sore mouth to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but could be between 66 to 67 years. The patient received Shingrix vaccination 3 days ago.  It was the first injection. The patient had no arm pain or other side effects other than on day 2 the patient started getting Cold Sores and very sensitive gums with some minor sore spots.  The patient did not know if the event was just coincidental or related to the injection  but it has been several years since the patient had sores of this type and magnitude. The patient did not expect any other side effects at the time of reporting.
burning stomach pain; burning stomach pain; Fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), ABDOMINAL PAIN UPPER (burning stomach pain) and DYSPEPSIA (burning stomach pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced PYREXIA (Fever), ABDOMINAL PAIN UPPER (burning stomach pain) and DYSPEPSIA (burning stomach pain). On 08-Apr-2021, PYREXIA (Fever), ABDOMINAL PAIN UPPER (burning stomach pain) and DYSPEPSIA (burning stomach pain) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
This spontaneous report as received from a pharmacist refers to a 59 year old male patient. There was no information about patient's concomitant medications, concurrent condition and medical history reported. On 16-OCT-2015, the patient was vaccinated with a first, 0.6 ml dose of expired dose of ZOSTAVAX lot # K008078, expiry date 03-SEP-2015, subcutaneously (site of administration was not reported) for prevention of shingles. No adverse events were reported. The patient's laboratory data was unknown. The pharmacist queried if she should revaccinate the patient. Additional information has been requested.
Feverish, chills, severe fatigue and mild headache for several days. Then the night of 2/7/2021 I began to feel slightly less sore, but I was unable to fall asleep despite exhaustion, and was awake until after 9:00am the following day at which time I was able to sleep about 2 hours. Awoke with a terrible headache.
Received MMR, Varicella, Comvax on 08/06/2002 - Rash started on 08/07/02 and seem on 08/08/02 with blanching erythamatous papules throughout face, body extremities, right thigh - indurated and red.
This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe chronic plaque psoriasis. The patient received ustekinumab (solution for infusion, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for drug used for unknown indication. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe chronic plaque psoriasis. No concomitant medications were reported.  On an unspecified date, the patient experienced kidney disorder, liver disorder, and skin plaque. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable; and treatment with ustekinumab, and adalimumab was withdrawn. The patient had not recovered from kidney disorder, liver disorder, and skin plaque. This report was non-serious. Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case is assessed as non-serious.
Erythema L deltoid area from Menactra IM 20 cm tip of clavicle to outer distal upper arm lateral aspect.
Burning stomach pain, feeling of fullness/bloating, feeling of fullness specifically on lower right side of abdomen.  Day 1 - Milk of Mylanta, limit diet to less spicy, lower fat food.  No alcohol, caffeine, carbonated beverages, chocolate.  Day 3 - Stopped taking all OTC meds.  A week later, fullness persists.
she got a lot of pain in the arm; This is a spontaneous report from a contactable consumer reported for herself. This female patient with unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 30Mar2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 on 09Mar2021 for COVID-19 immunisation. After the second dose, she got a lot of pain in the arm and she would like to know what can she use on herself to ease the pain. She had tried with hot water and it helped but the pain hadn't gone. The outcome of event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt developed inc fever about 4 1/2 hrs p/immun to 102- pt fussy & irritable & wouldn't eat; Rt arm swollen & warm to touch;
Vaccine received 9/30/23 11:00am, symptoms started 9/30/23 at 16:00: rash and skin irritation on face/neck
10 days post vaccine low grade fever (100.2 F) 11 days post vaccine low grade fever and red bumps around injection site on left thigh appears 12 days post vaccine no fever raised red rash appears on trunk 13 days post vaccine no fever raised red rash spread over whole body 14 days post vaccine no fever raised red rash begins to fade 15 days post vaccine no fever, rash almost completely cleared
2ND INJECTION ON 11-9-89. ONSET OF RASH(FINE RAISED, BRIGHT RED), ITCHING OVER WHOLE BODY, EYES SWOLLEN. TREATED /W/ PREDNISONE AND BENADRYL. RASH & EDEMA DECREASED BUT ITCHING TREATED /W/ HAOLG.POSS INTERACTION BETWEEN ENGERIX AND MAXZIDE.
Received FLUARIX QUAD flu shot 9/28/15 in left arm in deltoid. Pt still has a lot of pain to fingers. Describes as stabbing pain which radiates to fingers. Pt has trouble moving arm. Was referred to orthopedic dr.
This spontaneous report was received from a nurse referring to a 19 year old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a pediatric dose of VAQTA for prophylaxis (strength, route, frequency, lot/batch # and expiration date were not reported). Additional information has been requested.
Red, hot, itchy, hive-like swelling at the injection site -- approximate size of the affected area 4" x 3"
Rash to chest appearing approximately 4 days after injection. Spread to upper arms and low back.
pt recv vax 8MAR96 to a well child;approx 2 wk later devel rhinorrhea;approx 3 wk p/vax devel classic,diffuse erythema multiforme
No adverse action from vaccination. But I tested positive for COVID on July 14. I received a call today from the regulatory authority asking questions and they asked me to report here. Wednesday evening I had a sore throat. Woke Thursday to sore throat, head congestion, and swollen glands. Did a telemed call with physician, who prescribed Paxlovid. I will be taking the final dose this evening. I had some improvement on July 15, but symptoms continued. July 16 symptoms were nearly gone and felt good. July 17 and 18 (today) no symptoms at all.
pt rcvd vax; pt devel flu-like symptoms, aches, pains & nausea for 1 wk;
Fever, shaking, (+) tenderness on the injection site and erythematic nodule.