chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a licensed practical nurse through the pregnancy registry for GARDASIL concerning an 18 year old female with asthma and amoxicillin allergy who on 02-JUN-2008 was vaccinated with a first dose of GARDASIL (Lot # 659962/1740U) 0.5 ml intramuscularly. Concomitant therapy included prenatal vitamins. The nurse reported that the patient who received her first dose of GARDASIL is pregnant. No complications are reported. Medical attention was sought. On 19-JUN-2008, ultrasound revealed the patient had 10.1 weeks gestation at that time (gestation also reported as 5 weeks). Date of LMP was 09-APR-2008. Estimated date of delivery is 14-JAN-2009. There was no product quality complaint. Follow up information was received from a licensed practical nurse concerning an 18 year old female who on 02-JUN-2008 was vaccinated with a first dose of GARDASIL (Lot # 659962/1740U). Concomitant therapy included vitamins (unspecified). The LPN reported that on 19-JUN-2008 an ultrasound was performed which showed 10.1 weeks of gestation and confirm due date. On 22-AUG-2008 a routine ultrasound was performed: no problems were seen. The patient declined a Maternal Serum Alpha Fetoprotein Test. Date of LMP was 09-APR-2008. Estimated date of delivery is 14-JAN-2009. Follow up information was received from the pregnancy registry which reported that the patient delivered a normal healthy male baby on 15-JAN-2009. APGAR SCORE 8/9, weight: 8 pounds. The baby had no congenital anomalies, complications or abnormalities. The nurse reported fetal malpresentation and non reassuring fetal heart rate tracing during labor. It was also reported by the licensed practical nurse that the lot no. of first dose of GARDASIL was 661764/0650X (previously reported as Lot # 659962/1740U). Additional information has been requested.
2 doses in same day/3 doses overall; A spontaneous report was received from a physician concerning a 91-years-old male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and had 2 doses in same day/3 doses overall.  No medical history was provided. The concomitant medications were not reported.  The patient received their first of two planned doses of mRNA-1273 on an unknown date. On 25 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number: not provided), intramuscularly for the prophylaxis of COVID-19 infection.  On 25 Feb 2021, at 11:30 am, the patient received second dose of vaccine and on the same day, at 3:15 pm, at patient's assisted living home was inadvertently administered another dose of the vaccine making it two in the same day and three overall.  No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in response to the event is not applicable.   The event of 2 doses in same day/3 doses overall was considered resolved on 25 Feb 2021.; Reporter's Comments: This report refers to a case of extra dose administered for mRNA-1273 with no associated AEs.
Pt stated she had a rash, she saw her provider and he thought perhaps it was her stress and or new shampoo she started. She was already scheduled to see her provider, she did not see him because of the rash.
This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient's concurrent conditions and medical history were not provided. On 14-JUN-2016 the patient was vaccinated with improperly stored PROQUAD, 0.5 ml, subcutaneously (dose#, site of administration and lot# not reported). Concomitant medication was not mentioned. The registered nurse could not specify improperly stored conditions on PROQUAD. No adverse effects were reported. No further information was provided. Product quality complaint was not filed. Additional information has been requested.
Patient was vaccinated with 5-11 year old pfizer instead of  pfizer 12+
Child had chronic hives all over her body on and off for about 3 days - subsided once I administered BENADRYL regularly for the next few days. She continues to get hives randomly, unknown why at this time.
left arm started aching; eft arm became swollen; left arm became hot; rash break out over her left eyebrow,rash break out over the top of her left arm; soreness of the left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness of the left arm), PAIN IN EXTREMITY (left arm started aching), PERIPHERAL SWELLING (eft arm became swollen), FEELING HOT (left arm became hot) and RASH (rash break out over her left eyebrow,rash break out over the top of her left arm) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergic reaction to antibiotics, Allergic reaction to antibiotics (other antibiotics also (names not specified)), Hypothyroidism and Acid reflux (oesophageal). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), FAMOTIDINE, PANTOPRAZOLE and PROGESTERONE for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (soreness of the left arm). On 08-Mar-2021, the patient experienced RASH (rash break out over her left eyebrow,rash break out over the top of her left arm). On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (left arm started aching) and PERIPHERAL SWELLING (eft arm became swollen). 11-Mar-2021, the patient experienced FEELING HOT (left arm became hot). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. On 05-Mar-2021, PAIN IN EXTREMITY (soreness of the left arm) had resolved. On 12-Mar-2021, PAIN IN EXTREMITY (left arm started aching), PERIPHERAL SWELLING (eft arm became swollen) and FEELING HOT (left arm became hot) had resolved. At the time of the report, RASH (rash break out over her left eyebrow,rash break out over the top of her left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Pt stated prior to vaccine, "I'm very nervous, and sometimes I have panic attacks when I have medical procedures done." Pt had a near-syncope vasovagal response. Pt was sitting up in chair, talking to this nurse, when he stated "Yeah, I think I'm going to have a panic attack with this one." Pt sat on floor, with legs crossed et stated he felt dizzy, asked this nurse if she could hold on to his hand. While this nurse was holding pt's hand, pt began squeezing hand et started to shake, pt was also very diaphoretic. This nurse asked other nurse to get pt a bottle of water, when other nurse returned to room, she instructed pt to uncross his legs to help increase blood flow. Pt did  then asked if he could lay down on floor, both nurses stated yes. Pt layed on floor, et was very pale in color. Nurse began to 'fan' pt with paper, et talked to pt, color began to slowly return to pt's face. Pt stated he was feeling better, sat up again et drank some water. Pt stated he was feeling much better at the end of visit.
Previously healthy 14-year-old male with a history of extrinsic asthma, GERD, and allergic rhinitis, brought to the emergency department by his father complaining of fever, malaise, myalgias, worsening chest pain, and exertional dyspnea.  He had his Covid booster on Friday, and on Saturday he began to feel some generalized malaise, soreness at the injection site, and mild chest pain.  Over the last 24 hours the chest pain has worsened and he has developed exertional dyspnea with subjective feelings of shortness of breath at rest.  No vomiting or diarrhea, but has worsening myalgias and malaise.
ErythemaMultiform, UrticariaPruritus, Itching eyes and lip Narrative:  Allergic to foods. Started with itchy eyes and bottom lip. Progressed into itchy hands and neck. Monitored vitals and had pt stay 30 mins.
Booster was administered to a patient without being diluted; Booster was administered to a patient without being diluted; Booster was administered to a patient without being diluted; sore arm; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A 55 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 22Nov2021 15:00 (Lot number: FF2590) at the age of 56 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Abnormal Right Mammogram" (unspecified if ongoing), notes: Illness/AE: Abnormal Right Mammogram, Onset date: Unknown; "Thyroid Nodule" (unspecified if ongoing); "History of Severe Depression" (unspecified if ongoing); "ADHD" (ongoing). Concomitant medication(s) included: VYVANSE taken for attention deficit hyperactivity disorder (ongoing). Vaccination history included: Bnt162b2 (Dose: 1), for Covid-19 immunization; Bnt162b2 (Dose: 2), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious), OVERDOSE (non-serious), PRODUCT PREPARATION ERROR (non-serious), outcome "unknown" and all described as "Booster was administered to a patient without being diluted"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information  Response: Disclaimer noted. Spoke from the attached document under no diluent, resulting in higher than authorized dose. Do not repeat dose Inform the recipient of the potential for local and systemic adverse events. If the administration error resulted in a higher-than-authorized vaccine dose, in general the second dose may still be administered at the recommended interval. However, if local or systemic side effects following vaccination are clinically concerning (outside of the expected side effect profile), lead to serious adverse reactions, or are ongoing at the time of the second dose, the decision to administer the second dose may be assessed on a case-by-case basis.  The lot number for bnt162b2 was not provided and will be requested during follow up.  Follow-up (7Dec2021): This is a follow-up spontaneous report from a contactable nurse. This nurse reported in response to HCP letter sent included that:  Additional Information: First Name, Mailing Address, Patient Initial, Age at Vaccination, Product Coding, Biological Product, Dosage Regimens, Dose Description, Lot Number, Route of Administration, Anatomical Location, Best Doctor/Health Care Professional Information, Vaccine Facility Information, Concomitant Drug, Relevant Med History, Historical Vaccine. Booster dose due to high risk of frequent institutional or occupational exposure to coronavirus (and at risk of serious COVID-19 complications)
I received my first dose, I got a rash; I have it in my legs and in my arm; This is a spontaneous report received from a contactable consumer (patient).  A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, solution for injection, Batch/Lot Number: EW0182), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient never had rashes in the past. On an unspecified date, after receiving first dose, the patient got a rash and had it in legs and in arm. The patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, solution for injection, Batch/Lot Number: unknown) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The outcome of the event was unknown.   No follow-up attempts are needed. No further information is expected.
Redness, induration - 2.8 cm x 3.3 cm on anterior aspect of (L) thigh. Non-tender. Mother advised to do warm soaks.
This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen arm) and FEELING HOT (warm arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (swollen arm) and FEELING HOT (warm arm). At the time of the report, PERIPHERAL SWELLING (swollen arm) and FEELING HOT (warm arm) outcome was unknown. Not Provided          Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.
DTaP, IPV and ProQuad vaccine given within 1 minute he was pale, nauseated, vomited, developed periorbital swelling, itching of hands and feet with agitation. Was given Benadryl 25mg by injection, O2 at 2 liters, ambulance to ER.
Narrative: Pt was tachycardic, lethargic, tachypneic, hypotensive. Rapid response team called, patient able to self-cardiovert.
General malaise, fatigue, arm pain at injection site and lingering intense soreness, body rash on upper torso (looks like a German measles or scarlet fever flush), some itchiness.  *No Fever*  Have been treating every 4-6 hrs with extra strength Tylenol.
Initial report received on 29 October 2007 and follow-up received on 07 January 2008 from a health care provider. The initial information received contained listed events; and, upon follow-up, the final diagnosis was an unlisted event. A 58-year-old female patient, with no illness at the time of vaccination, had received a left deltoid, intramuscular injection of FLUZONE SV 2007-2008, lot number U2464AA, on 26 October 2007. Twenty-four hours post-vaccination, the patient experienced redness and swelling of approximately half of the area between the shoulder and elbow, and the injection site was warm to touch. The diameter of the area was approximately three inches. The final diagnosis of the event was aseptic cellutitis. Treatment included TYLENOL and KEFLEX. The patient subsequently recovered on 05 November 2007. The reporter for this case is the same as for case 2007-03679.
Developed warmth, redness, swelling, left deltoid only after receiving DTAP, MMRV Left Deltoid on 7/11/11. Seen on 7/13/11.
Post vaccine, patient described chest pain, metallic taste in mouth, dry tongue and L foot tingling.
Developed rash on palms and swollen, painful, reddish/purplish color to right pointer finger. Pain in right hand joints as well.
Patient was found supine on ground complaining of shortness of breath and chest pain, was diaphoretic and disoriented. Oxygen placed on client via mask at 2liters and VS obtained.  Pulse-127, B/P- 146/56. Patient's legs elevated above head. Patient responded to touch stimuli and would then respond verbally.  Patient was suspected of having anaphalaxic reaction due to complaining of being unable to breathe.  Epi 0.3mg given to right thigh.  The facility had Epi Pen available and was used. 911 was called and patient was monitered until first responders with ambulance came and transported to emergency facility.  VS were continued to be monitered until transported.  Final VS prior to transport were; HR- 113, B/P- 142/52.
7hr p/vax was given-had inconsolable crying, low grade fever;taken to ER-told was immun & sent home;instructed to give motrin & see regular MD;pt was taken to MD next day told it was the immun;
fever; body aches; headache; flu-like symptoms; This is a spontaneous report from a non-contactable consumer. A 27-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 27Jan2021 (Batch/Lot number was not reported) as SINGLE DOSE, COVID-19 immunization. Medical history included unknown from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 28Jan2021, by midnight, patient experienced fever of 101, body aches, headache - flu-like symptoms; lasted +/- 24 hours. Felt well enough on 29Jan2021 to go back to work. The outcome of events was recovered.  Patient did not received treatment due to events.  Information on the lot/ batch number has been requested.
This spontaneous report was received from a back office lead and refers to a 63-year-old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. On 11-FEB-2016, the patient was vaccinated with an improperly stored dose of hepatitis b vaccine (recombinant) (manufacturer unknown) (1 ml, left deltoid, route of administration: intramuscularly, dose number not reported, lot number: L038499, expiry date: 26-JUN-2017). Concomitant therapy was not reported. There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Breakthrough case admission after 2 vaccines Janssen 3/25/21 lot# 01802072;  Moderna 1/27/22 lot# 013H21B
Immediate and gradually worsening pain in arm. Around 6pm, started to feel extreme fatigue, dizziness, chills. By 7pm severe chills and nausea which lasted all night. Alternating shaking and chills with sweating and overheating. Severe headache (like migraine). Full body pain. Took Tylenol in the morning (7am).  Chills mostly stopped around 8am, but aches and fatigue continued. Continued needing tylenol for 48 hours for pain and headache. Dizziness, nausea, and fatigue persisted.  One week after vaccine, fatigue continues with mild body pain.
Pt states she went to ER and DX with Covid was given IV fluids on 11/7/21
Mother reported fever to 102 and brief apneic episode. Not sure if true apneic never cyanotic but rolled eyes back in head and went limp. No tonic clonic movements-called EMS went to BMH where limited workup was unrevealing. Occurred within 12 hours of immunizations. Fever resolved within 48 hrs. Seemed fine and never developed other symptoms.
SLIGHT TENDERNESS IN ARM LIKE ANY SHOT; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced slight tenderness in arm like any shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of slight tenderness in arm like any shot was not reported. This report was non-serious. This case, from the same reporter is linked to 20210900481.
This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. Medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with a stored improperly dose of (Oka/Merck) VARIVAX (dose, route, lot number and expiry date were not reported). No adverse effects reported. There was no concomitant medication provided. This is one of several reports received from the same reporter. Additional information has been requested.
This is a spontaneous report obtained from a contactable physician (patient's mother) reported for her son. A 18-year-old male patient received the second dose of TRUMENBA, (Lot. M37315, Expiration date: 30Apr2017) on 06Apr2016 14:03 at 0.5 ml single dose, intramuscular in the left arm. The patient was vaccinated at private doctor's office and was purchased with private funds. Medical history included asthma (from 2000 and ongoing) and attention deficit/hyperactivity disorder (ongoing). Concomitant medication included oral VIVACE, 60 mg, daily (ongoing, started about 5 years before this report). The patient previously received the first dose of TRUMENBA on 16Dec2015 14:03 at 0.5 ml single dose, via intramuscular route on left arm. On 16Dec2015 the patient experienced chills, fever, very bad body aches, couldn't move arm extending to clavicle, felt weakness in both arms, worse in the arm where the injections was given. After the second dose, on 06Apr2016, the patient experienced clavicular pain, chills, body aches and fever. Clavicular pain started the same night, but not immediately. An emergency room or doctor visit were not required. The patient recovered from the event, clavicular pain, on 10Apr2016; while recovered from the other events on 08Apr2016. The events were considered related to TRUMENBA. Follow-up (07OCT2016): Follow-up attempts are completed. No further information is expected.
Arm is swollen; Lymph nodes are swollen; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021.    This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021.    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 PERIPHERAL SWELLING (Arm is swollen) and LYMPHADENOPATHY (Lymph nodes are swollen) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Arm is swollen) and LYMPHADENOPATHY (Lymph nodes are swollen). At the time of the report, PERIPHERAL SWELLING (Arm is swollen) and LYMPHADENOPATHY (Lymph nodes are swollen) outcome was unknown.            No concomitant medications were reported. Treatment medications were not provided by the reporter. Action taken with mRNA-1273 in response to the events were not Applicable.
Swollen knot about the size is a silver dollar at the injection site that lasted 3 days
Seizure activity.  On call physician aware upon transfer to hospital on 7-21-08.  09/10/2008 MR received for DOS 7/29-8/4/2008 with DX: New onset seizures. Pt transferred from local facility after several episodes of twitching of arms & legs, eyes rolling, unresponsiveness and pallor on 7/28/08. Takes ~ 3 minutes to recover. Witnessed episode at 1st hospital. Ophth consult due to poor tracking. Initially poor blink to light, repeated with indirect ophthalmascope with good blink.  Possible cortical etiology to decreased visual function. Started on phosphenytoin.
extreme nausea, headcahe, slight fever, muscle soreness all over the body especially shoulders and back