chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning an approximately 30 year old who was possibly exposed to her 15 year old vaccinated niece who developed chickenpox and was scabbed all over on 5/4/98. It was reported that the 15 year old was vaccinated on 4/15/98. Subsequently in 1998 possible secondary transmission was reported ant the pt died presumably from chickenpox. The physician was not aware if the pt had been in contact with her niece or had any exposure to chickenpox. Additional information has been requested. Follow-up from the physician reported that the pt was taking steroids for an unknown cause. It was reported that her child developed natural chickenpox, that the pt was exposed to her child and subsequently died. The physician did not know the cause of death but she "felt that it was from natural chickenpox and she did not think that this was a complication from the vaccine." The physician did not have any further details because they were not her pts. It was reproted that the pt's niece had no history of chickenpox and was vaccinated with the first dose of varicella vaccine live after exposure to her cousin, the pt's child, who had natural chickenpox. No further info is expected.
Left side of body - left breast sensitive, left kidney pain, whole left side numb after sleeping on that side. Arthritic pain increased significantly. Numbness went away after a couple days. All other symptoms except arthritic pain subsided but still feel a little. Significant arthritic pain still the same as of now.
pt recvd vax & 12 days later, pt devel a psychotic reaction characterized by confusion, agitation, hallucinations, & horrifying dreams; had dec appetite & sleep; believed had inc physical strength & extra sensory powers;
fever; tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tired) and PYREXIA (fever) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced FATIGUE (tired). On 08-Mar-2021, the patient experienced PYREXIA (fever). At the time of the report, FATIGUE (tired) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Mar-2021, Pyrexia: 100.9.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not reported.  Treatment information was not provided.
Onset of 7/10 left-sided chest pain and left arm pain described as tightness. Dizziness and nausea. EKG and 12-lead, patient transported to  Hospital
Pt complained 3 days after receiving her first dose of the Hepatitis B Vaccine that on the day she received it she had a fever of 99.8, racing heart, upset stomach and felt like vomitting. She also complained that her bottom lip and right side of face (side vaccine administered on) felt "puffy". States she took tylenol and went to bed and symptoms were gone when she woke up.
12/25/03 Left shoulder pain develops. 12/26/03 Went to doctor for pain relief. By the end of the day, I cannot rotate the left arm forward or outward. Follow up 02/03/05: I still have not recovered from the adverse event. Where as I could not lift my arm more thatn 10 degrees from the vertical, after 14 months, I can now lift it to the horizontal. I cannot hold it for more thatn a minute. I have obtained an opion from a neurologist and her opinion was that it was "unlikely" that the vaccine caused my injury.  Per Annual follow up report: residual shoulder weakness.
This spontaneous report as received from a pharmacist refers to an approximately 63 year old female patient with no pertinent medical history or known drug reactions or allergies. No information regarding the patient's concurrent conditions was provided. On 08-APR-2016, the patient was vaccinated with a dose of ZOSTAVAX injection (lot# and expiry date were not reported), 0.65 ml subcutaneously. Concomitant therapies included MOTRIN (it was also reported that the patient had no concomitant medications). On an unknown date in April 2016, reported as "over the weekend", the patient developed a 3 inch area of redness around the injection site, which was swollen and warm to the touch. She sought medical attention by returning to the pharmacy on 11-APR-2016. No treatment was given for the event and no diagnostic lab studies were performed. The outcome of the event was reported as not recovered. The relatedness between ZOSTAVAX and the events was not provided. Additional information has been requested.
Moderna Booster shot, 1/2 dose. Slight swelling of throat, tongue. Reaction lasted less than an hour.  It was much milder than the first two Modern doses. With the first two doses, I took Benadryl 30 min before hand, my reaction spiked after the shot, and then plateaued, resolving about four hours later. My allergies can be ?dangerous? but have never hospitalized me.
Got the vaccine, 4 months later shingles/suspected vaccination failure; worst case of shingles ever.; Sick for a month.; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 4 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and sickness. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and sickness to be related to Shingles vaccine.     Additional Information: GSK receipt date: 24-OCT-2022 Reporters comment: This case was reported by the patient via interactive digital media. The patient received Shingle vaccine and had the worst case of shingles ever and was sick for a month. Additional Supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Patient stated broke out in hives one day after the vaccination.  Patient stated took benadryl.  I advised patient to seek medical attention.
extreme symptoms of Tourette Syndrome; 1st dose, 28Apr2021; 2nd dose, 12May2021; This is a spontaneous report from a non-contactable consumer (patient). A 20-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 12May2021 (at 20-year-old, non-pregnant at time of vaccination) as dose 2, single for covid-19 immunisation. Medical history included ongoing chronic pelvic pain, depression, eczema from an unknown date and unknown if ongoing. Prior to vaccination, the was not patient diagnosed with COVID-19. Concomitant medication included etonogestrel (NEXPLANON). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously had known allergies: doxycycline. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 28Apr2021 (at 20-year-old) as dose 1, single for covid-19 immunisation. The patient experienced extreme symptoms of Tourette Syndrome on 01Jun2021. She had minor, unnoticeable symptoms of Tourette's until experiencing extreme sudden onset sometime after vaccination. The event resulted in doctor or other healthcare professional office/clinic visit, not resulted in hospitalization prolonged. Seriousness criteria were reported as disability and medically significant. Therapeutic measures were taken as a result of event Tourette Syndrome included guanfacine and recommended therapy. The outcome of the event Tourette Syndrome was not recovered. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
HCP called to report an AE regarding the ROTATEQ vaccine. HCP reported that the patient regurgitated the ROTATEQ vaccine. HCP provided limited pertinent information and had no further clarifications. Request case 02504635 filed. Permission to contact; This spontaneous report was received from a Physician and refers to a 2-month-old male. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies, and concomitant therapies were not reported.   On an unknown date, the patient was vaccinated with Rotavirus Vaccine, Pentavalent (ROTATEQ), (strength, dose, frequency and units were not provided), administered Orally for prophylaxis (lot # 1965643 has been verified to be a valid lot number with the expiration date as 05-OCT-2024; anatomical location were not provided)  The causal relationship between the event and rotavirus Vaccine, Pentavalent (ROTATEQ), was unknown.
less than 4 hours aftoer vaccine developed shortness of breath whihch was still on going on the 22nd but much less.  Also lightheaded ness and vision out of focus with in foru hours after vaccie and lasting 36 hours  Gave Prednisone 40mg on 3/22 for SOB as patient also has hisotry of asthma, patient to foolowup if anny changes occur
Pt was here yesterday for her annual immunization of influenza vaccine, after immunization pt tolerated well with no problem or reaction. Today pt came back to the office with severe discomfort and burning sensation in the vaccine area, after I checked it, I can observe several blisters in the vaccine area as an allergic reaction. Dr. states this is a reaction to the trivalent Flu vaccine not to the administration. Pt is coming tomorrow for follow up.
had vaccine on 3/10 was fine until 3/13 at 3pm got extremely fatigued and around 6pm had chills and fever woke up drenched in AM, 3/14 around 6 got chills and fever woke up, drenched in AM, 3/15 around 6pm got chills and fever woke up at midnight with my heart pounding, final calmed down a bit an went back to sleep woke up drenched in sweat again.  3/16 started getting chills again around 4pm have slight temp.
swelling of lt arm;mom claims that pt recv vax 2 days prior;mom returned on 17MAY to obtain addtl tx for rxn, t98, induration +, swelling +,
Friday, developed rash on body, Saturday developed muscle aches and Sunday developed a fever of 101.9
No additional AE's; Temperature excursion / temperature 6.134 F; This spontaneous report was received from licensed vocational nurse and refers to a 12 months old patient of unknown gender. There was no information regarding their medical history, concurrent conditions nor concomitant therapies provided.  On 08-AUG-2021, a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) dose/frequency reported as 1 (units not provided), lot # T029535, expiration date 01-SEP-2022 was stored improperly in a temperature of 6.134 degree Fahrenheit (F) for 30 minutes and on 09-AUG-2021 (described also as this morning), it was administered to the patient (exact dose, route of administration and anatomical location were not provided) for prophylaxis. No previous temperature excursion was reported. The patient was asymptomatic and no adverse event was reported.  This is one of two reports from the same reporter.; Sender's Comments:  US-009507513-2108USA002735:
Onset of symptoms started after receiving Hep B #2, weak, headache, sensitivity to light sweaty, chills, diarrhea, stomach cramps Treated in the ER 10/10/07 and 10/14/07
Elevated T of 100.3, body muscle/joint pain; severe headache, nausea, dizziness
Case number PHEH2014US019684 is an initial spontaneous report received from a medical assistant on 29 SEP 2014. This report refers to a 61 years old male patient.  His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN 2014/2015 (batch number: 141001/141301) intramuscularly at a dose of 0.5 ml on unspecified date between 19 SEP 2014 to 23 SEP 2014. It was reported that the patient received FLUVIRIN that was stored at a temperature of -1.7 to 11.8 degree C for 191 hours. No adverse events reported after the maladministration (incorrect storage of drug).
Information has been received from a Registered Pharmacist (RPh) concerning his 29 year old female associate who was accidentally exposed to an unknown amount of ZOSTAVAX (Merck), once, on 09-MAY-2011. Concomitant therapy included hormonal contraceptives (unspecified) (birth control pills). The patient had no relevant medical history or relevant concomitant medication. Her relevant past drug history was unknown. On 09-MAY-2011, about 90 minutes ago, the associate was administered ZOSTAVAX (Merck) to a pharmacy's consumer and accidentally, due to a needle dysfunctioning, she got some of ZOSTAVAX (Merck) into her both eyes. On 09-MAY-2011, she reported to the pharmacist that both of her eyes were hurting and stinging. There was no relevant laboratory data. As of 09-MAY-2011, she was no longer exposed to ZOSTAVAX (Merck) and her eyes continued to hurt and sting. It was unknown if the patient sought medical attention. Additional information has been requested.
Patient reported feeling flush of heat. patient SP02 98%, 88 pulse, 125/97. patient recovered without intervention and left for home.
Information has been received from a nurse concerning a 36 year old female who on 11-SEP-2007 was vaccinated subcutaneously (site not reported) with the 1st 0.5ml dose of PNEUMOMAX 23 (lot # 655500/1005F). On 12-SEP-2007 the patient developed a large local reaction at injection site and a low grade fever. The patient received unspecified medical attention on 14-SEP-2007 and recovered on an unspecified date. Additional information has been requested.
Information has been received from a licensed practitioner nurse concerning a 72 year old female patient with diabetes, allergies to prednisone, cortisone, NEOSYNEPHRINE and BENTYL, who in 2003 was vaccinated with a dose of PNEUMOVAX 23. Concomitant therapy included influenza virus vaccine (unspecified). On 10-NOV-2008 the patient experienced a localized reaction after receiving a second dose of PNEUMOVAX 23 (lot # 657143/0380U). The patient symptoms included redness and swelling of her arm, the patient called the doctor's office. The localized reaction, redness and swelling persisted. This is one of two reports received from the same source.. Additional information has been requested.
1st dose 05Sep2020, 2nd dose 22Aug2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number 2LH9L, expiry date 4th October 2022) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 5th September 2020, batch number T2CS3, expiry date 1st December 2021).   On 22nd August 2021, the patient received the 2nd dose of Shingrix. On 22nd August 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The patient received 2nd dose of Shingrix later than the recommended time interval, which led to lengthening of vaccination schedule. The reporter stated that, the patient said, they were not told to come in for second dose in appropriate time frame. The reporter consented to follow up.
The patient had an episode of syncope after she received her H1N1 immunization at 1pm. She had not had any lunch prior. She usually experiences near - syncopal episodes when she sees blood or has blood work done but never with just a shot. She lost consciousness but was aware of person, place and time.
Inflamed skin; Rash face, neck arms and ears; Itchy skin; Red skin; Rash face, neck arms and ears; Rash face, neck arms and ears; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old, non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: N6201) via an unspecified route on 26Feb2021 at 12:00 hours in left arm (at an age of 70-year-old) as single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. The medical history included pollen allergy. The patient received calcium (MANUFACTURER UNKNOWN), retinol (VITAMIN A), colecalciferol (VITAMIN D3) received on unknown dates within two weeks of vaccination for unknown indications. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN5318) via an unspecified route on 03Feb2021 in left arm at 10:30 hours as single dose for COVID-19 immunisation. Post the vaccination, the patient was not tested for COVID-19. On 27Feb2021, the patient experienced rash face, neck, arms and ears, itch and red or inflamed skin. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included treatment with topical cream and a ten days course of prednisone. The clinical outcome of the events of inflamed skin, rash face, neck, arms and ears, itchy skin and red skin was recovered on an unknown date in 2021. No follow-up attempts are needed. No further information is expected.
Pt developed Rt. thigh swelling and papular rash on entire right thigh. Then the left thigh the next day also developed the same symptoms. No fever, no irritability. Mom used warm compress on swollen Rt. thigh.
Medication Administration Error - Only Diluent Given: Patient received her first dose of Pfizer COVID-19 mRNA vaccine on 2/11/2021, second dose on 3/4/2021, and third dose on 10/7/2021. After vaccination with the third dose, the medical assistant realized only diluent was administered to the patient. The patient was notified of the error and returned to the clinic on the same day to receive properly diluted Pfizer COVID-19 mRNA vaccine.  All COVID-19 vaccine administration halted at clinic until staff training/competency around Pfizer vaccine dilution can be implemented with two-person preparation process/verification to be implemented.
First dose of the SHINGRIX shot was given at the same location on:  8 September 2018.  Adverse reaction after first dose began in January ~ paralyzed bowels, extreme abdominal pain, chills, extreme weakness, nausea, loss of appetite.   4-6 weeks later, I began having extreme chest pain and made numerous trips to the ER.  In June 2019, I began having daily rashes that emerged every morning and every evening, lasting less than 30 min. each time.  Since June 2019, I began having painful lymph nodes in my left breast.  In the past 2 months, the rashes now come randomly throughout the day and last for varying times.
Began at 4 am on 3/25 Sore arm at injection site, nausea, headache, fatigue, and chills. Fever was 100.2. Took Tylenol and fever wouldn?t go under 99.6. All symptoms were gone except for fatigue after waking up the morning of 3/26.
This case was reported by a healthcare professional and described the occurrence of stomach cramps in a 18-year-old female subject who was vaccinated with Engerix B (GlaxoSmithKline). There were no concurrent medications. On 3 October 2007 the subject received 2nd dose of Engerix B at at 20 mcg in the left arm. On 3 October 2007, less than one day after vaccination with Engerix B, the subject experienced severe stomach cramps. It was not known how long the cramps lasted, but they reportedly resolved. The healthcare professional considered the event was possibly related to vaccination with Engerix B.
COVID diagnosis; coughing; low oxygen; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (COVID diagnosis), COUGH (coughing) and HYPOXIA (low oxygen) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced COUGH (coughing) (seriousness criterion hospitalization) and HYPOXIA (low oxygen) (seriousness criterion hospitalization). On 24-Feb-2021, the patient experienced COVID-19 (COVID diagnosis) (seriousness criterion hospitalization). At the time of the report, COVID-19 (COVID diagnosis), COUGH (coughing) and HYPOXIA (low oxygen) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Feb-2021, Antibody test: negative (Negative) Negative. On 19-Feb-2021, Oxygen saturation: low (Low) low.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment information was not given.  This case concerns a 63-year-old male hospitalized with serious unexpected events of COVID-19 and cough. Event onset 5 days after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 63-year-old male hospitalized with serious unexpected events of COVID-19 and cough. Event onset 5 days after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2), in Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), in Feb2021 as dose 1, single (Batch/Lot number: unknown), in Mar2021 as dose 2 , single (Batch/Lot number: unknown) and in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "HTN (controlled)" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Ibuprofen, reaction(s): "Known allergies: Ibuprofen". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19".The patient underwent the following laboratory tests and procedures: COVID-19 treatment: Positive, notes: Recurrence of COVID 4 days after the last dose of Paxlovid. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Adverse event: Recurrence of COVID 4 days after the last dose of Paxlovid. Device timestamp: 20Jun2022.  Follow-up attempts are completed. No further information is expected.