chrisvoncsefalvay/vaers-outcomes huggingface dataset:
*Menstrual Cycle: Abnormal cycles.  The second dose coincided with the start of menstrual bleeding, cycles are normally 5-7 days.  This one lasted 13, with clotting and watery, brown discharge for four days at the end.  Next cycle was also mild clotting.  Has resolved. *Fatigue: started day after dose 1, lasted for 3 days; started again day after dose 2 and lasted for 2+ months.  Especially noticed after moderate exercise.  Not normal fatigue, it was like she had been out in the sun too long and was exhausted.  It took the rest of the day+ to resolved with each instance.   *Hollow-head: 5 days post dose 1; worse after dose 2, lasted about 1 week.  Not your normal light-headedness.  It felt like it was made of stone and filled with helium.  Lots of 'empty space' but hard and heavy.   *Joint pain and stiffness: started day after dose 1, lasted 4-5 days; started day after dose 2 and has not resolved as of today (8.12.2021) *Peeling feet: both heels of feet and bottoms of toes peeled June 20th-June23rd, completely.  I (mom) wouldn't have thought about this being a side effect, except I belong to a adverse event vaccine group myself and see this reported frequently by people who have had worse reactions.
Patient received vaccine #3 on 10/22/2021; he developed fever, unsteadiness and lethargy on 10/23/2021; he was seen in ER on 10/23/2021 and was admitted to Hospital on 10/23/2021 for acute hypoxic respiratory failure, seizure disorder and acute metabolic encephalopathy; he was discharged on 10/28/2021.
This is a spontaneous report from a contactable other healthcare professional (patient). A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0158 and expiration date not provided), via an unspecified route of administration administered in the right arm on 11Apr2021 14:00 as  a single dose for COVID-19 immunization. Medical history included Crohns Disease. The patient is not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient has no known allergies. There were no concomitant medications. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. On 12Apr2021 01:45, about 12 hours after the first dose, the patient passed out and then broke out in a cold sweat, multiple times. No treatment was given in response to the events.  The outcome of the events was recovering. The patient has not been tested for COVID post vaccination.; Sender's Comments: Based on the plausible temporal association and product safety profile, the reported events are possibly related to the vaccine BNT162B2. administration. This case will be reassessed upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer drug 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.
Phone call received from hospital states that patient came to ER with rash illness on Saturday 4/12/03. Today she was seen by doctor who feels strongly that this is generalized vaccinia. Phone call to client: she states she had close contact with a military policeman and was vaccinated approximately one month ago. She states his site was covered. on 4/7/03, she noted a lesion on her forehead. Thought it might be ringworm 2 hours to contact with kitten, but by 4/11/03 had developed multiple lesions that looked like ant bites but progressively worsened. Now states she had approximately 70 lesions to both legs and 30-40 on arms, more on left than right. She also has lesions to face and neck. Some are producing exudate; they are very itchy and she has taken Benadryl for relief. Advised her about prevention of spread of vaccinia: good hand washing, washing of clothing separately, no dry cleaning, proper denies any personal risk factors or household members with risk factor. She has been advised to seek medical attention for worsening of symptoms. As of now her symptoms include lesions and itching only. Health department has been notified as well as doctor and the military vaccine line. A VAERS form will be completed. Also discussed with patient prevention and follow up of inadvertent eye inoculation in case that should occur.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with a dose of improperly stored PROQUAD (albumin status: recombinant human albumin), subcutaneously, lot # M033215 with expiry date 09-JAN-2018 (exact dose was not reported). The dose was exposed to the temperature higher than 46 degrees Fahrenheit but lower than 77 degrees Fahrenheit for 36 hours. There were no previous temperature excursions. Digital data logger was involved. No adverse effects were noted. Additional information has been requested.
This was a 65+ flu shot. My whole upper arm swelled and really itched. It is now Nov, 18, 2021, and it still itches a good bit, even though the swelling is about gone. I had no other reactions to the shot.
We have a question for you about a possible reaction to the rabies vaccine. We have a 31 year old female with a Dx of lupus and Raynaud's. She is to leave the country in August. Last Wednesday, 5/9/12, she received her first rabies vaccine. She immediately felt numbness in her legs and feet then told us that after shot #1, several hours later, her legs were "tired", as if she had "run 5 miles". The symptoms lasted no more than 30 minutes. We did read that on very rare occasions, the rabies vaccine can cause numbness and transient paralysis. She is not allergic to eggs, the only medications that she takes are oral contraception and spironolactone 50mg Bid. She has no known drug allergies. Please give your opinion about the third shot. We have asked her to send an email to her doctor who manages her Lupus. We have asked her to keep us informed of how she is feeling.
12/18/2020 9:00PM Body aches, fatigue, headache and chills; Tylenol dose. Symptoms have not subsided; have continued to today 12/29/2020. 12/28/2020 Swollen lymph nodes left armpit, extremely fatigued and headache. 12/29/2020 Clinic visit  with NP, Flu -- negative and COVID 19 test taken -- no results yet. Advised to continue Tylenol for treatment.
Information has been received from a consumer concerning her friend's 19 to 20 year old daughter who was vaccinated with the first and second dose of Gardasil. She indicated that her daughter developed "cancer cell" after the second dose. The patient had pap smear before the first dose and had normal results. However, after the second dose about  a month ago the patient had abnormal pap smear results, "cancer cells," which had to be removed. It was indicated that cancer cells were removed and the patient was fine. Unknown medical attention was sought. The patient was recovered. No product quality complaint was involved. On 30-OCT-2007 the followup information indicated that the patient never received the third dose of vaccination. This is one of two cases from the same source. Additional information has been requested.
4/10 slight redness at site, 4/11 increase red, warm arm, 4/12 increased red, warm, pain 3x2.5cm circular area left deltoid + erythema, pain, warmth, edema, 4/12 Depro Medrol 40 Mg.
Patient is fully vaccinated.  COVID + at ED visit on 3/1/2022. Approximately 29 weeks gestation presents to the ED complaining of shortness of breath and fever. + cough. O2 sat 95% on RA. CT chest: No acute pulmonary process. No PE. EKG: ST.  Treatment:  tylenol, decadron, fluid, robitussin, iopamidol.  Patient discharged home.
TESTED POSITIVE FOR COVID19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (TESTED POSITIVE FOR COVID19) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension (blood pressure med). Concomitant products included AMLODIPINE for Blood pressure high.    On 28-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Dec-2021, the patient experienced COVID-19 (TESTED POSITIVE FOR COVID19). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) ongoing since an unknown date for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (TESTED POSITIVE FOR COVID19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Dec-2021, COVID-19 screening: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications were not provided by the reporter. Company comment: This is a spontaneous case concerning a 61-year-old, female patient with a history of hypertension with concomitant use of amlodipine, who experienced the non-serious unexpected AESI of COVID-19. The event occurred 18 days after the first dose of mRNA 1273 vaccine. The patient started experiencing symptoms such as throat irritation and nasal congestion and tested positive for COVID-19, 3 days later. The rechallenge was not applicable. The medical history of hypertension remains a confounder in this case. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 22-Dec-2021: Significant follow-up received. Information on patient's lab data, suspect product, concomitant medications and treatment medications were updated, and new events were added according to follow-up document. On 22-Dec-2021: Follow up document received, contains Non-Significant information On 22-Dec-2021: Follow up document received, contains Non-Significant information; Sender's Comments: This is a spontaneous case concerning a 61-year-old, female patient with a history of hypertension with concomitant use of amlodipine, who experienced the non-serious unexpected AESI of COVID-19. The event occurred 18 days after the first dose of mRNA 1273 vaccine. The patient started experiencing symptoms such as throat irritation and nasal congestion and tested positive for COVID-19, 3 days later. The rechallenge was not applicable. The medical history of hypertension remains a confounder in this case. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Starting 02/2022, my menstrual cycle was late by 5 days and it lasted for about a week. Then, after a few days of no period, it started again. Since then, I have had 2 periods every month to this day. My periods have normally been regular and I'm still having the burning mouth as well.
Information has been received on 06-JUN-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient"s concurrent conditions, medical history and concomitant medications are unknown. In January 2014, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In July 2016, the patient was treated at a family medicine office for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient has suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Local reaction, pink with induration 2cm x 1 1/2cm Per completion of questionnaire additional symptoms noted were that injection site was warm to touch, slightly swollen, and tender.
Internal Hemorrhage (GI) & urinary Muscles aches chills (L) side pain after 2 days post COVID vaccine #1 & after 1 day post COVID vaccine # 2 Hemorrhoids, bright red blood per rectum. Saw GI doctor. C/o platelet count (low normal)
Chills; Achy; This is a spontaneous report from a contactable consumer (patient). A 90-year-old female patient received second dose (PFIZER-BIONTECH COVID-19 VACCINE,  Lot Number: EN6201; Expiration Date: 30Jun2021), via an unspecified route of administration, administered in the right arm on 15Feb2021 (age at vaccination was 90 years) as single dose for COVID-19 immunization. The patient was vaccinated at a hospital. Medical history and concomitant medications were not reported. Historical included first dose of bnt162b2 (lot number: EL9262, expiry date: 31May2021), via an unspecified route of administration, administered in the right arm on 25Jan2021 and experienced diverticulitis. The patient experienced chills and achy on 16Feb2021 12:00 with outcome of recovered on 16Feb2021 19:00. The events were reported as non-serious.  No follow-up attempts are possible. No further information is expected.
Red skin at injection site approx 19-20 hours after PNEUMOVAX injection.  About 2" around site.  Warm to touch.  Dr's office contacted patient told to watch & go to ER if any breathing problems.
Itchy raised rash over large area of body 12 hours after vaccine. Large area of welt left arm and left chest. Took 3-4 days to resolve.
About 11-13 minutes after the injection I got very fuzzy or light headed, then my diaphragm felt like it had a weight sitting on it making it hard to breath from below my breasts. Rapid shallow breathing even when I was trying to focus to breath slower and deeper. My Heart rate was over 100 floating between 99->120. My blood pressure was constantly changing  (normal for me is lower than average 110/60) spiking as high as 160/90's, pulse ox fluctuated from low 90's - 97. They put an ice pack on my diaphragm. Within around 15-20min my  breathing improved with weighted feeling improvement.  Then my forehead and outer eye muscles started twitching, progressing to my eye muscles causing my eyes to cross involuntarily. That progressed to right sided face twitching also. Then that progressed to right arm numbing deep in my arm to twitching fingers, then right leg. This progressed to right sided partial paralysis I could move my limbs with alot of effort and focus, but it was uncoordinated and they were hard to feel (numb). This progressed to unable to speak well, my mind was aware, but my body was not in my full control. I still had involuntary twitching around my eyes, forehead, right side of face, right arm to hand, right leg to foot.
Fever and chills. Bones ache so much, I had to sit out in the sun. It made my bones feel better. Headache lasted for 4 days. I still have aching bones.
I walked around the store for about 20 seconds. My arm started burning and throbbing. I walked into the aisle and sat my phone my card and keys on the shelf. I got light headed and told my friend that I felt weird. I grabbed the shelf and next thing I remember is him telling me to get up and trying to help me. I had passed out and was going into a seizure. I lost all functions of my bladder. Because I urinated on myself when I fell out. I was soaked in urine and sweat. I didn't report it. And just walked out because I was in shock I guess. But it's been 2 hours and I still feel sick. Nausea's
no adverse event; ROTATEQ was administered to a patient after temperature excursions; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.   On 26-SEP-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally for prophylaxis. Lot # was reported as W002561 which was valid for rotavirus vaccine, live, oral, pentavalent (ROTATEQ), expiration date 07-OCT-2023 (exact dose, dose # and anatomical location was not provided). The reporter stated that rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was administered to the patient after temperature excursions (product storage error). Temperature and time frame were reported as: 1 hour at 9.13 Celsius (C); 37 hours and 15 minutes at minimum of -8.45C. There was no previous temperature excursion. No additional adverse event information provided.
Pt described swelling and rash in left arm injected with Shingrix on 9/25/20 at 5pm after getting vaccination in the morning that day.  Pt states that she took 2 Benadryl 25mg that night, and then continued her regular loratadine 10mg nightly.  Pt then described a rash on her back on Wednesday 9/30/20 in the AM after showering.  Recommended that the patient replace her loratodine 10mg in the evening with 2 Benadryl 25mg and monitor and follow up with primary care.
PT stated she was feeling hot and shaky, as well as her tongue having a slight tingling sensation as well as her throat being dry, and a heavy feeling in her chest. PT was very anxious during the event. RN was notified immediately vitals were taken, and given Benadryl 25Mg IM in the R arm, EKG was performed and reviewed by a DR, and bedside glucose test was performed as well with normal results. EMS was called and the PT was transferred to the emergency room for further evaluation.
Patient stated that their legs fell out from under them the morning after receiving all four vaccines. Patient denies loosing consciousness or any symptoms of  syncope or loosing consciousness. Patient was brought to the ER and was kept in the hospital for a three day stay. Stated that she the hospital was not able to determine the cause of her fall.
Patient reported feeling nauseous and light-headed post-vaccination. EMS evaluated her, determined her blood pressure was low, and gave her snacks and water. Patient was driven home by her mother.   6/1/21:10:50am -  TC to mom - daughter is doing fine and have no concerns or questions.  -  RN
11 year old old was vaccinated with Flublok during a fair today, no adverse event; Initial information received on 22-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case was linked with 2019SA294934 (same reporter)  This case involves a 11 years old male patient who received a dose of influenza quadrivalent recombinant vaccine [Flublok QIV] during a flu fair (Product administered to patient of inappropriate age).  On 22-Oct-2019, the patient received a dose of suspect influenza quadrivalent recombinant vaccine [Flublok QIV] (lot QFAA1930, expiration date: 30-Jun-2020) via intramuscular route in the left arm.  It was a case of actual medication error due to inappropriate age at vaccine administration.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient is a 44 y.o. male with past medical history of WPW, who presents to the Emergency Department with chief complaint of as mentioned above.   Patient dates that he has been ill for about 10 days with flulike symptoms including a cough, headaches, diffuse myalgias and generalized weakness.  About 5 days ago he was diagnosed with COVID-19 after testing positive at pharmacy.  He has been self isolating at home.  His sister who is a nurse had sent him a pulse ox and warned him to monitor for hypoxia.  The patient has admitted that he has been very weak and mostly just lying in bed.  He has very poor appetite.  He has had low-grade fevers and chills.  He endorses dyspnea with exertion.  He was seen in the emergency department yesterday and was not hypoxic.  He returns today with worsening shortness of breath and noted that his oxygen saturations were dropping into the 80s.  The emergency room he was indeed found to be hypoxic with an x-ray consistent with Covid pneumonia and is being admitted to hospital for further evaluation and treatment.  Incidentally, the patient completed his Pfizer Covid vaccination in March 2021
Seizure (possible initial syncopal / pre-syncopal episode but followed by tonic-clonic movement, posturing and altered mental status).
Patient was admitted to the hospital with COVID 19 without hypoxia being a secondary diagnosis. No systemic steroids or remdesivir were given to him.
Client and family were exiting the facility when the client became unsteady on his feet and had an episode of syncope. Family helped client to the ground. Client had received 3 vaccines and a TB skin test. We assessed client and father helped client to an upright position and placed him in a chair. Client was diaphoretic. We gave him 2 bottles of juice. Vitals signs were taken at 2:19pm: BP75/30, HR 65. (per machine). BP rechecked manually at 2:25pm and was 110/56. Client did c/o blurry vision at the time he had the syncope episode. Family refused ambulance service. Client recovered and went home with family. Family given instructions to take BP every hour and drink lots of water by nurse practitioner and if in doubt take client to urgent care or ER for follow up.
had both shots and still got them / suspected vaccination failure; got and dealing with them now/ horrible flare ups; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine and Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 26-JAN-2023 Reporter's comments: This case was reported by the patient via interactive digital media. The reporter stated that he/she had both sets of shots and still had them and was still dealing with them at the time of reporting. The flare-ups were horrible. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible, as no contact details were available.  As this case had no follow up that could be obtained thus conservatively two doses were coded based on reported verbatim without dose number as the patient received 2 sets but number of doses was unknown.
2nd dose given too soon. 1st COVID vaccination given on 1/6/21 2nd COVID vaccination given on 1/20/21