chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a 64-year-old female patient with no pertinent medical history who has a sulfonamide allergy, who on 29-JUN-2007 was vaccinated with an "injection in the left arm" of Zostavax (Oka/Merck) (product circular# 9815603).  Concomitant therapy included SYNTHROID, diclofenac and simvastatin (MSD).  On 01-JUL-2007 the patient developed red and itch fluid-filled blisters on her left foot.  They were not clustered, but the physician diagnosed them as shingles.  She has since developed one of the blisters on her left arm.  Unspecified medical attention was sought.  There were no laboratory diagnostic studies performed.  The outcome is reported as not recovered.  No product quality complaint was involved.  Additional information has been requested.
Patient had delayed onset of Swollen Face and Hives after vaccination. Vaccinated at noon and started having symptoms around 8pm.
Information has been received from a physician concerning an approximately 12 month old (reported as "1 year of age") patient who on approximately 06-FEB-2009 ("1 week ago") was vaccinated with MMR II. Concomitant therapy included VARIVAX and PEDVAXHIB which were vaccinated on the same day. Other concomitant therapy included DTaP (unspecified) which was also vaccinated on the same day. Subsequently, the patient experienced measles like rash and abscess (at the injection site) and maculopapular rash. On unspecified date, the patient contacted the physician. The physician stated the vaccines were not given in his office and he does not know which vaccine was given in the area that has the measles like rash and abscess. At the time of reporting, the outcome was unknown. Additional information has been requested. This is in follow-up to report(s) previously submitted on 5/29/2009. Follow up information was received via phone call. It was reported the physician did not remember the patient and did not have additional AE information. No further information was available.
Patient who had presented with 'HPV infection, warts on face and hands' was administered GARDASIL 9 on unknown date with, following Corresponding GARDASIL 9 administration, Corresponding Patient's 'warts cleared up' / 'infection cleared up with; This spontaneous report was received from a medical doctor and refers to a female.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On unknown date, the patient had presented human papillomavirus infection (HPV), warts on face and hands. Then on unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection(strength, lot #, expiry date, and route of administration were not provided) administered for prophylaxis. Following hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) administration, patient warts cleared up and infection cleared up within 3 months. On unknown date, the patient expirienced unexpected therapeutic benefit. At the time of the report, the patient had the human papillomavirus infection (HPV), warts on face and hands lested for 3 years. Caller was unable to further clarify these statements at current call time. No additional adverse event (AE) was reported and no further information provided.
Initial report was received on 08 October 2013 from a health care professional. A 55 year-old female patient with a past medical history of hypothyroidism had received on 22 October 2009 a dose of H1N1, lot number UP001AA (route and site of administration not reported) and three days later on 25 October 2009, developed fainting spells. According to the reporter, multiple tests were conducted to establish causality (results were not reported). Concomitant medications included SYNTHROID. Illness at the time of vaccination was denied. No further information was available at the time of the report. The patient's outcome was recovered. Documents held by sender: none.
Extreme lupus flare up, followed by complete debilitating period of about 1 hour.  Husband found me with muscles fully relaxed to a point of him being concerned and started talking to me.  I was conscious but felt too heavy to move at all.  With effort I could move and answer coherently.  It was as if I had melted on the couch  buy was fully awake.................
Vaccine administered. PCP reported that patient was given an influenza vaccine on 2/3/04 in geriatric clinic. Following day, he reported feeling ill, vomiting, weakness, fell; was admitted to hospital for 2 days for severe myalgia. Nurse follow up on 06/28/04 states: "ADD: Headache, hypokalemia, anxiety, decreased appetite, rash."
Headache, Fever, body ache. chills, sob, fever Narrative:  Other Relevant History:
Patient had s pain in their stomach,  felt dizzy and then fainted.  Patient fell to floor but was unharmed.  Pt recovered without injury quickly without injury.
Pt vax w/ hepta B. 4 days later devel arthralgia, which resolved over next few days. nurse attrib. pt exp to hepta B vax.
Patient received 9 vaccinations (Hep A, HepB, HPV, Meningo, MMR, polio, SARS-COV2, Td/TdAP, Varicella) at center and after release, presented to Hospital with left-sided facial paralysis, paresthesias, left ear swelling, tinnitus, vesicular rash in ear, now spreading to his arm and leg. Consistent with Ramsay-Hunt Syndrome and concerning for disseminated VZV.
Swelling and redness at site of injection. After reviewing the chart, it was noted that the pneumo shot was in the arm that reacted. The influenza shot had been in the other arm. It was the right arm that reacted.
I began having arthritis in my hands followed by all joints in my body becoming red and inflamed causing unbearable pain and inability to move. This caused me loss of work and serious pain. Within a few months after my Covid-19 vaccines I got a case of shingles beginning at the injection site of my left arm and running all the way down my arm to my hand and back behind my left shoulder causing more unbearable pain and injury. I still suffer from pain and have been on Gabapentin for three months now with no resolution to the pain. I am on a constant rotation of Ibiprophin and tylonol every three hours on top of the Gabapentin. My life has been full of pain and loss of work since my first Covid-19 vaccine.
Expired vaccine used; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 29-Oct-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.   Treatment medication was not provided.  Concomitant medication was not provided.
Initial misuse report received from a healthcare professional (Nurse) on 12 March 2014. A 9-month-old patient has received only DTaP IPV portion of PENTACEL on unspecified date. It was an underdose. No adverse event was reported. List of documents held by sender: none.
Encephalitis reaction: high pitched screaming for 18 hours, intensely high fever, unable to bear weight on legs the following day
Severe pain in left arm (still in pain 1/20), unable to move arms above head (lasted 5 days for both arms), Chest pain and squeezing sensation in chest and both arms (lasted 6 days), altered heart rate (lasted 2 days), internal swelling (was told this is what was causing the "squeezing" sensation)
pt recv 2nd vax 1MAR99 1:45PM; pt seemed fine until 10:30PM when mom noticed a fine pinpoint rash;pt was fussy & not eating as much as normally does;mom took pt to ER for treatment;
Mouth and face shingles; This is a spontaneous report from a contactable physician. A 89-year-old male patient received second dose of bnt162b2 (BNT162B2, Solution for injection) intramuscularly in right deltoid on 27Jan2021 as single dose for COVID-19 immunization. Medical history reported was hyperlipidemia, osteoporosis, chronic ischemic cardiovascular disease (CICD III), stroke prevent, all ongoing. Concomitant medications reported was atorvastatin (LIPITOR) for hyperlipidemia, acetylsalicylic acid (ASPIRIN) for stroke prevent, all ongoing and via orally route. Patient previously received first dose of BNT162B2 (lot: EH9899) in right deltoid on 06Jan2021 for covid-19 immunization. The patient experienced mouth and face shingles on 25Feb2021. Patient was hospitalized from 28Feb2021 to 03Mar2021. Treatment was received as tramadol for and Gabapentin for shingles. Outcome of the event was recovered on an unspecified date.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Herpes zoster cannot be totally excluded The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
pt recv vax 1/14/92 & on 6/29//98 lab eval revealed a lack of seroconversion, zero titers;
I received the vaccine around noon on the 17th and by the evening (around 7) my hip was sore along with the injection site. By the next day I had severe muscle and joint pain on my right side and soreness, redness and slight swelling at the injection site (left bicep), the pain continued and was unable to work on Saturday, slight improvement on Sunday with taking Tylenol.
Both hands turned blue; some tingling discomfort left elbow area. Left hand still remains blue now 5 days later.
Pt is 77 yo female s/p Pfizer COVID vaccination: dose 1 on 3/1/2021 and dose 2 on 3/22/2021. ESRD on HD, DM2, HTN, nonobstructive CAD, and hx R breast cancer 2017 s/p mastectomy and chemotherapy who was admitted on 8/19 for shortness of breath secondary to COVID-19 pneumonia. CTPE confirmed bilateral pneumonia without PE. Completed course Remdesivir. Started on 10 day course Decadron while inpatient of which she will finish at home. Patient meets criteria for extended DVT prophylaxis in COVID-19. She was discharged on Eliquis 2.5 mg BID for 30 days.
Nervous system affected, dystonic activity that had been well managed with reduced  to no meds for past couple years; issues occurred 3 days after 1st vaccination (Pfizer) impaired mobility, speech, vision, seizures( NE), fatigue, low energy/weakness; challenges continued couple  weeks after frequency increased noticeably from the previous status prior vaccination     Also joint issues have intensified considerably
Shingrix administered without reconstitution; Shingrix administered without reconstitution; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 51-year-old male patient who received Herpes zoster (Shingrix) (batch number E42J2, expiry date 10th July 2023) for prophylaxis.   On 10th October 2022, the patient received the 2nd dose of Shingrix (intramuscular). On 10th October 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 11-Oct-2022 Reporter's comment: The clinic director of operations reported that the patient was seen in office one day before the reporting day for Shingrix administration (the first of a two part series).  The suspension component was drawn and injected into patient's right deltoid without first reconstituting the antigen component. No adverse reaction was noted. The patient was then administered a properly reconstituted dose on the same day. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Additional supportive information: The patient received Shingrix vaccine without antigen component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Information has been received from a nurse practitioner concerning a 15 year old female who was the daughter of the nurse practitioners patient. It was reported that on 02-SEP-2007 the girl was vaccinated (dose not reported) with HPV rL1 6 11 16 18 VLP vaccine (yeast) (Lot# not reported). Subsequently, the girl experienced that her menstrual period was delayed two weeks post vaccination. Subsequently, she recovered from the delayed menstrual period. It was also reported that the patients other daughter had the same experience (WAES# 0710USA6260). Additional informtion has been requested.
Information has been received from a 77 year old female with osteoporosis, high blood pressure and amoxicillin allergy who in April 2007, was vaccinated with a dose of ZOSTAVAX. Concomitant therapy included SYNTHROID, alendronate sodium (MSD), calcium (unspecified), TOPROL XL TABLETS, CRESTOR, PAXIL and VICODIN. IN end of June 2007, the patient experienced fractured ankle and was hospitalized. It was reported that the in end of June 2007 patient was walking down steps and fell resulting in a broken ankle. The patient was currently in a rehabilitation hospital and having daily physical therapy. The patient's son thought the fall was because she was taking VICODIN. on approximately 27-JUN-2007 the patient developed shingles on her face from her cheekbone into her hair line. The patient stated that the pain was excruciating and her eyeball hurts. No diagnostic laboratory tests were performed. At the time of report the patient was not recovered. A product quality complaint was not involved. Additional information has been requested.
30 hours, post vax, pt's right thigh had redness, swelling and warmth. The whole thigh was red and swollen; redness down past knee. His fever was 106.6 (oral).
Incomplete course of vaccination; Pain at site of injection; Redness at site of injection / Redness extended all the way to the elbow; Swelling of the bicep; This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 26th November 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On 27th November 2019, 1 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced injection site pain, erythema and muscle swelling. On an unknown date, the patient experienced incomplete course of vaccination. On 29th November 2019, the outcome of the injection site pain, erythema and muscle swelling were recovered/resolved. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the injection site pain, erythema and muscle swelling to be related to Shingrix.  Additional details were provided as follows: The patient received the 2nd dose of shingrix after more than recommended time frame which led to incomplete course of vaccination. The patient received the 1st dose on 26th november 2019 and experienced erythema, injection site pain and muscle swelling which was recovered in 2-3 days. The reporter consented to follow up. No further information was available.
Severe dizziness could not stand or walk, went to ER and tested for stroke MRI of the Brain, CAT Scan of the head and neck admitted into the hospital for observation was perfectly in good health until after receiving the vaccine
Site: Pain at Injection Site-Medium, Systemic: paralysia of right arm tingling difficulty holding stuff-Severe, Systemic: Neurological Disorder (diagnosed by MD)-Medium, Additional Details: pt went to ER got CAT scan done. no neurologica damaged found. have primary care visit this week.
No adverse effects; the patient was inadvertently administered a dose of expired VAQTA; This spontaneous report was received from a medical assistant and refers to a 2-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant drugs were not reported.  On 10-APR-2019, the patient was inadvertently vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) intramuscularly, lot number R007211, expiration date 02-APR-2019 (exact dose, frequency and site of administration were not reported) for prophylaxis. No adverse effects were reported.
This spontaneous report was received from a 60 year old male patient with unspecified thyroid condition and unspecified drug allergy. On 15-SEP-2015, the patient was vaccinated with a single dose of ZOSTAVAX 0.65 ml, subcutaneous injection and unspecified pneumonia shot. Concomitant therapies included unspecified thyroid medication. On 17-SEP-2015, the patient developed rash that had spread all over his arm (arm unspecified). The patient decided to take BENADRYL on his own. The patient did not seek medical attention. No lab diagnostic test was performed. At the time of the report, the patient did not recovered from rash. Relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Dizzy H/A Shakey Stable vitals  pt monitored for an additional 30 min provided fluids pt brought to the ER at 816 am
Patient states she was diagnosed with a pulmonary embolism on 4-23-21. She states 2 weeks after her vaccination (4-7-21) she noticed shortness of breath, fatigue, brain fog, and "burning lungs" . She says she has a stressful job and her lungs would feel like they are on fire. She was seen by Dr in urgent care on 4-23-21. She says she was seen by Dr (in the absence of her regular provider) on 5-21-21. She was started on Eliquis 5mg BID on 5-21-21. She also was seen by Dr of Hematology Oncology to evaluate her after the vaccination also. Referred to Pulmonary Dr. seeing on 7-8-21
11/13/06 Patient seen rash on body since 11-10-06, nauseated raised bumps on back , head, stomach, axillary region, right side of face. Itchy. Temp 98.0, Pulse 80 rate 14. Diagnosed chicken pox post varicella vaccine admin. Prescribed Acyclovin 800 mg 4 times a day for 5 days. Chickenpox precautions. 10/28/06-Varicella zoster IGM/IGG negative
This case was reported by a pharmacist via call center representative and described the occurrence of herpes zoster in a 74-year-old male patient who received SHINGRIX (batch number 3Z4KL, expiry date 30th January 2020) for prophylaxis. On 19th February 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In April 2018, 61 days after receiving SHINGRIX, the patient experienced herpes zoster. On an unknown date, the outcome of the herpes zoster was unknown. It was unknown if the reporter considered the herpes zoster to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient developed herpes zoster approximately 2 months after receiving SHINGRIX. The health care professional had reached out to the patient for schedule dose 2 of SHINGRIX and when he got know that the patient had an active case of herpes zoster. The health care professional did not speak to the patient directly at that time. The health care professional would soon reach out to determine if there was treatment or symptoms resolved. The batch number updated from 324KL to 3Z4KL as per sales data sheet.
Rash, Mild Lip swelling  Patient called Allergist she told him to take Benadryl and predasone   also NOT to get the second dose in 4 weeks. she did tell him to get J and J vaccine in 4 weeks
Patient was given the vaccine in the afternoon of 9/25/19, the next morning she woke up and had hives.  She was given Benadryl and the child was improving.  On 9/28/19 The child was feeling better but still had a rash on her trunk.  On 9/29/19 the rash was worsening and the child was seen by her physician who said "the vaccine could have provoked some kind of virus" and the child was given Prednisolone x3 days.  She had never had any previous reactions to the flu vaccine.  The incident was reported to Nursing Services by the school nurse.
fever (100.5 F) all day and night; pain at the injection site; chills; headache; fatigue; This is a spontaneous report from a non-contactable consumer via medical information team. A female patient of unspecified age received of BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection Lot number and expiry date: unknown), via unspecified route at unknown date at single dose for COVID-19 immunization. Relevant medical history included: The patient had a serious case of Covid-19 in unspecified date in Mar2020. Concomitant medication was not reported. On an unspecified date in Jan2021, after receiving the vaccine, the patient had fever (100.5 F) all day and night, chills, headache, fatigue, and pain at the injection site. She had antibodies 2 weeks ago on 15Jan2021. The patient did not need information and just wanted to help other people by reporting the side effects she experienced. The patient did not receive any treatment. Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Presented to ED with shortness of breath, chills, productive cough, nausea, vomitting, diarrhea, and weakness.  Started on Decadron, remdesivir, combivent, albuterol, Vitamin D3, ZInc, melatonin, and oxygen Discharged home with decadron, singulair
dehydration; Chills; low fever; nausea; body ache; fatigue; headache; This is a spontaneous report from a contactable consumer, the patient. A 78-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EN9581, second dose) solution for injection intramuscular in the right arm on 19Feb2021 at 10:30 (at the age of 78-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension and overweight. Concomitant medications were not reported. Historical vaccine included BNT162B2 (first dose, lot EN5318) for COVID-19 immunisation on 26Jan2021 and experienced dehydration, fatigue, chills, headache, fever, nausea, body ache, and cough. On 19Feb2021 at 18:00, the patient experienced dehydration, chills, low fever, nausea, body ache, fatigue, and headache which resulted in an Emergency Room visit. The patient was treated for dehydration. The outcome of the events dehydration, chills, low fever, nausea, body ache, fatigue, and headache was recovered in Feb2021.  Information on Lot/Batch number was available. Additional information has been requested.
Chills, body aches, runny nose, Headache, Temperature 99.4, lymph node swollen and tinnitus.
Went medical center on 6-27-20 for redness, swelling and sensitivity was administered Keflex for possible cellulitis. Went back to medical center on 6-28-20 for follow up. Arm is looking better per Physician. Swelling has subsided, smaller than original outline of marker.
Patient stated that his arm swelled up, was painful and turned black and blue. He stated the swelling and pain went away in about 10 days but still black and blue. He applied ice once as the only treatment.
Patient should have received PEDIARIX HIB PCV.  Instead, received PEDIARIX HIB DTaP.  DTaP was inadvertently ordered and given on 3/5/21.  Will contact mom and monitor patient for any adverse outcome.
SEVERAL HOURS AFTER RECEIVING THE VARICELLA VACCINE, THE PATIENT EXPERIENCED BLISTERS ON HER BODY. THE BLISTERS RESEMBLED VARICELLA INFECTION.