chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a healthcare worker refers to an unspecified patients of unknown age and gender. The patient's medical history and concurrent conditions and concomitant medications were not specified. On an unknown date, the patients were vaccinated with improperly stored doses of VAQTA, lot # K012457, expiry date 04-JUN-2017, (dose and frequency not reported). No adverse experiences were reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Pt with gradual onset of peripheral neuropathy, weakness, absent reflexes bilateral upper/lower extremities, slurring of speech and difficulty swallowing.
I take the city bus across town and i had to take 2 buses and i got to work and it was raining, i got soaked. I walked into work and clocked in and went to go put things in order on the shelves and somebody was standing across from me and i just sneezed really hard. It became hard to breathe and i had to take a second to try and catch my breath and it felt like my throat locked up. I went to the back to try and catch my breath, and i asked to leave early and they ignored me because they didn't believe that i was sick. The shields at work were dirty and i didnt know if that had something to do with it.
It was reported that  9 days posts vaccine (3/7/03) the pt was afebrile, rash on back and shoulders.
left shoulder soreness (1/2 of a day), mild headache (1 day), fever 101.8 (3 hours), tachycardia 100-130 beats per minute (1 day so far), left eye conjunctivitis (just started an hour ago)
died two weeks later from ITP; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNE THROMBOCYTOPENIA (death, medically significant), outcome "fatal", described as "died two weeks later from ITP". The patient date of death was unknown. Reported cause of death: "Immune thrombocytopenia". It was not reported if an autopsy was performed. Clinical Course:Female Reporter stated that she would like to be vaccinated with Pfizers Covid 19 vaccines but she was concerned because she has ITP Idiopathic thrombocytopenic purpura that she developed during her third pregnancy in 2002 and continued on until 2015 She states she has been in remission and her platelet counts have been within normal range for the last 5 years. She stated that she had Covid last year in Aug and did well . She stated that she was nervous because a Doctor in withheld took the vaccine and died two weeks later from ITP and he was healthy prior. She stated that she has been staying home and wearing a mask and waiting for more research but she has not seen any new information yet. Her hematologist relayed that getting any vaccine would be a risk for worsening ITP They suggested that she get the first shot and see how it goes and then wait 3 months to get the second shot Also relays that she has autoimmune disorder Hashimotos. She would like to know if there is any information or new data that would help her to know what her risks are when getting the Pfizer Covid 19 vaccine with ITP.    The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: Immune thrombocytopenia
Pt recvd 3 doses of Engerix-B vax & titers were checked 6 months p/last dose; titer reuslt was 6.7 indicating a low pos response;
This spontaneous report as received from a physician refers to a 61 years old female patient. The patient was vaccinated SC. into left arm with a dose of ZOSTAVAX (lot # (670820/0660AA, expired date 04-AUG-2012), 0.65 ml, on 09-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. It was unknown if the patient had sought medical attention. Additional information is not expected.
Injection site was red, swollen, and itching; Injection site was red, swollen, and itching; Injection site was red, swollen, and itching; Sore arm; A spontaneous report was received from a consumer concerning herself, a 46-year-old female patient, who received Moderna's COVID-19 vaccine and experienced injection site being red, swollen, itching and sore arm.  The patient's medical history was not provided.  Concomitant medications were not reported.  On 06-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273(Lot number: 025L20A) intramuscularly in the right arm as prophylaxis of COVID-19 infection.  On an unspecified date in Jan-2021, after receiving the first dose of vaccine, the patient (clerical service rep at a hospital) had experienced sore arm for a few days.  On 14 Jan 2021, when patient woke-up, she had experienced injection site being red, swollen, and itching. Reporter provided consent to follow up. No treatment information was provided for the event.  Action taken for the events injection site being red, swollen, itching and sore arm were not reported.  The event, injection site being red, swollen and itching were considered to be not resolved. The event, sore arm, was considered to be resolved on an unspecified date in Jan-2021.; Reporter's Comments: This case concerns a 46 year-old, female patient, who experienced events of injection site being red, swollen, itching and sore arm.  The event of sore arm occurred for a few days after the first and only dose of mRNA-1273 vaccine administration. The events of injection site being red, swollen, itching  occurred 9 days after the first and only dose of mRNA-1273 vaccine administration. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded and the events are assessed as possibly related.
fever; body aches; not feeling good; This is a spontaneous report received from a contactable consumer (Patient). A female patient of an unspecified age received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), Solution for injection, via an unspecified route of administration on 24Feb2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Feb2021, the patient experienced fever, body aches and not feeling good. The outcome of events was unknown.   Follow-up attempts completed. No further information expected.
Three days post vax pt experienced itching of right wrist, and pinkness of legs, arms and scalp. By the next afternoon pt developed large welts all over and ears were red. Pt went to urgent care and was told it was an allergic reaction to something, possibly flu vax. Pt treated with Benadryl.
The evening of injection, started with muscle spasms and aching  in deltoid. Over the next day the pain worsened and spread up into my neck, shoulder  and down into elbow and forearm. The pain is intense 7/10 and constant. Pain is disrupting my daily activity and sleep. I?ve tried ibuprofen, Tylenol, voltaren gel, lidocaine patches, icy hot, Celebrex,   bio freeze, steroid injection, toradol injection, tramadol, multiple massages, hot showers, ice, tens unit, cbd oil.  All of these treatments have done very little for the pain
Localized rash around influenza vaccine site, that subsequently generalized to total body rash supports vaccine reaction to influenza vaccine.  Pt. otherwise appears well. Rash does not look like IgE mediated rash- ie skin lesions do not look like hives. Advised oral Benadryl q 4 to 6 hours prn itching. Discussed question of influenza vaccine allergy. Advised father I would list the vaccine as allergy, but cannot conclude 100% that rash is true allergy based on exam of rash. Father provided list of allergists- would consider allergy assessment next year before making decision about flu vaccine, consider vaccine under supervision of allergist.  Pt. is here for evaluation of a rash in association with flu vaccine received two days ago. Mother forwarded picture day after vaccine showing what appears to be local swollen erythematous reaction, surrounded by smaller macular appearing lesions. Father notes rash progressed, total body yesterday, and has seemed a little itchy. No breathing difficulties reported, no vomiting or diarrhea, no fever.
Patient reported that her right arm was still extremely sore three weeks after receiving Prevnar13 vaccine.  Advised her to take Tylenol for the pain based off med profile as well as increase arm movement.
Began to itch around 2:00 p.m. on Tuesday, December 21, 2021. Itching got progressively worse throughout the afternoon and evening. Went to bed with severe itching around 10:00 p.m. On Wednesday, December 22, 2021, I woke up around 1:30 a.m. to extreme itching on my stomach, thighs, and hips. I noticed hives in those areas. I took a cool shower and took 50 mg of Benadryl. This calmed the hives and itching. I went back to sleep. Around 6:00 a.m. I woke up to my face red and swollen, hives behind my knees, on my stomach, and on my arms. I then went to a local emergency room to be seen. They diagnosed it as contact dermatitis and gave me three Prednisone pills as well as a prescription for four more Prednisone pills to be taken once a day for the following four days. I was advised to also continue taking 50mg of Benadryl every 4-6 hours as needed. Throughout the next 4 days, I took the Prednisone as prescribed and continued to take the Benadryl every 4-6 hours throughout the day. I still developed hives and noticed that when I scratched my skin, it became red and raised with the exact same pattern as how I scratched. On December 24, 2021 I wrote the word "hi" on my skin with my nail and it became raised and red within a few minutes and stayed visible for around 30 minutes. I then looked up those symptoms and became aware of dermatographia. On Thursday, December 30, 2021 I made a virtual doctor's appointment where the physician confirmed it was dermatographia and she suggested I take Zyrtec once daily and to take Benadryl as needed if any other symptoms worsened throughout the day. I have been taking 1 Zyrtec every morning since Friday, December 31, 2021. Since beginning the daily Zyrtec, I have not had any hives but my skin does show the exact pattern of any scratches in red marks.
CHILD DEVELOPED LARGE AREA OF SWELLING ON THIGH (MOM DID NOT REPORT UNTIL 2/17/04) BUT UNSURE WHICH THIGH.  SWELLING BEGAN 8/22/03 AND WAS SIZE OF "BASEBALL" BY 8/23/03.  WAS SEEN IN ER AND GIVEN BENADRYL/ICE PACK.  CHILD FULLY RECOVERED WITH NO LONG LASTING ILL EFFECTS.
After administration of intranasal influenza vaccine on 2 separate occasions. Patient developed rhinitis and a erythematous, tender rash on tip of nose.
NOTHING OCCURED TO CHILD, CHILD WAS GIVEN 0.1ML OF PFIZER.
This is a spontaneous case, initially received from physician on 21-Nov-2018, concerning a 28-year-old, adult female patient. The patient had unspecified respiratory allergies in the past (reported as medical history). The patient did not receive any concomitant medications. On an unspecified date in 2015, the patient was administered influenza vaccine (route of administration: intramuscular, anatomical location: deltoid, dose, batch number, expiry date, trade name and manufacture: not reported). On the same day, 6 hours after vaccination, the patient experienced respiratory difficulties. The patient was treated with albuterol and the event resolved on the same day. The reporter assessed this case as non-serious.
Patient complains of soreness after shot was received on 11/3/2014. Lingered on for 2-4 weeks, or more especially when applying pressure or leaning on arm that shot was received. Soreness has subsided but still is experiencing some irritating pain when leaning on the arm. Have spoke to her PCP for treatment.
Erythema multiforme; asthma attack/shortness of breath/cough; Rash started on legs on the 03Apr2021 late morning buy next day (04Apr2021) full body rash from shoulders to top of feet; extreme exhaustion; This is a spontaneous report from a contactable consumer (patient). A 68-years-old non-pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER 8730), via an unspecified route of administration, administered in left arm on 02Apr2021 09:15 as single dose for covid-19 immunisation. Medical history included heart disease, high blood pressure, asthma, drug hypersensitivity and wasp stings. Concomitant medication(s) included amlodipine; aspirin and atorvastatin. The patient was not pregnant at the time of vaccination. The patient had no other vaccine in four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 03Apr2021 09:45 late morning, the patient experienced rash started on legs by next day (04Apr2021) full body rash from shoulders to top of feet. Later on 03Apr2021, extreme exhaustion and dry cough that went into shortness of breath and asthma attack. Visit to ER and later sent to dermatologist. Possible Erythema multiforme. As of 09Apr2021 still have rash and exhaustion and dry cough. It was unknown whether patient received any treatment. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Light flashes (started on 5/10/99), tingling and numbness in feet (started approx. 6/99), intense back pain (started 6/21/99), weakness and numbness in both arms and right hand (started 12/15/99). Numbness in feet is daily; other symptoms, including hand cramps that started later, are intermittent. 60 day follow-up states the pt also experienced neck stiffness and visual problems.
Numbness and tingling on lips and tongue, fatigue,  throat tightening, back of thigh swelling, feverish, and pain. lasted at least 3 days but resolved. All issues completely resolved in a week.
missed the second dose due to not showing up on the scheduled date with no adverse event; Initial information received on 18-Sep-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 19-years-old female patient who had missed the second dose of rabies (HDC) vaccine [Imovax Rabies] due to not showing up on the scheduled date with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 15-Sep-2023, the patient missed Dose 2 of suspect rabies (HDC) vaccine, powder and solvent for suspension for injection (batch number, expiry date unknown) via unknown route in unknown administration site for immunization due to not showing up on the scheduled date with no adverse event (product dose omission issue) (unknown latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  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 the 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.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 29-APR-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion three times. The total cumulative excursion time of the first time was 212 hours with the lowest recorded temperature of 34 Fahrenheit degree. The total cumulative excursion time of the second time was 24 hours with the highest recorded temperature of 49 Fahrenheit degree. The total cumulative excursion time of the third time was 792 hours with the lowest recorded temperature of 29 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Menstrual cycle disruptions. Experienced spotting prior to first period after the first shot, and period started 5 days early.  The next period in between the first and second shots lasted 10 days whereas my periods normally last 4-5 days. After my second shot, my period was 10 days late and was accompanied by severe cramping.
Patient stated she had chest pain and her back hurt. she turned her oxygen up. looked like she wanted to keep throwing up
rapid pulse rate, severe pain/itching, sharp pain w/resp lt side, reddened area-2cm very red, 7cm pink area surrounded site, edema-shoulder to finger tips lt hand;fine rash on back;chills
Flush face, blotchy skin, high blood pressure, rapid pulse, tingly fingers. Given 50mg Benadryl
Swelling at left thigh (where injection given), left ear swelling, erythematous papular rash at left/ midline chest. Given ibuprofen with improvement in swelling. On exam I did not see ear swelling.
Itch at injection site; redness at/around injection site; lingering stiffness at/around injection site.
on 8/23/2021 I got the second dose of the vaccinated and a few days later i noticed a blister on my right breast.  I did not report it then because i did not think nothing about it.  So, on 7/25/22 I got the 3rd dose and i got another blister in the same spot on my right breast.
I had local redness and tenderness at injection site for three days. I received the Evusheld vaccines on 07/27/2022. I tested positive for COVID-19 via both home and PCR test on 09/07/2022. I had a sore throat and body aches on 09/05. I developed nausea, dizziness and sweating on 09/06. Later that day, I developed cough and nasal congestion with fatigue.  I continue to test positive for COVID-19 as of today. My doctor put me on Paxlovid but I only took it for two days. The side efforts of Paxlovid was terrible. I had extreme diarrhea and an altered taste like a metallic taste. The fourth vaccine I had body aches and a fever for 24 hours.
On Monday he woke up with pain around the injection site. At school while the on playground he lost his breath he proceeded to past out. He vomited the nurse contacted us. The nurse also reported he mentioned that his heart was racing. I took him on Monday afternoon to see his pediatrician his heart rate went from 80 to 100. The doctor advised us to get him a EKG. Due to his sister being in close contact having COVID we had to reschedule his appointment.
nausea, aching, runny nose, loose stool, instantly have cold; nausea, aching, runny nose, loose stool, instantly have cold; nausea, aching, runny nose, loose stool, instantly have cold; nausea, aching, runny nose, loose stool, instantly have cold; nausea, aching, runny nose, loose stool, instantly have cold; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea, aching, runny nose, loose stool, instantly have cold), PAIN (nausea, aching, runny nose, loose stool, instantly have cold), RHINORRHOEA (nausea, aching, runny nose, loose stool, instantly have cold), DIARRHOEA (nausea, aching, runny nose, loose stool, instantly have cold) and NASOPHARYNGITIS (nausea, aching, runny nose, loose stool, instantly have cold) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced NAUSEA (nausea, aching, runny nose, loose stool, instantly have cold), PAIN (nausea, aching, runny nose, loose stool, instantly have cold) and NASOPHARYNGITIS (nausea, aching, runny nose, loose stool, instantly have cold). On an unknown date, the patient experienced RHINORRHOEA (nausea, aching, runny nose, loose stool, instantly have cold) and DIARRHOEA (nausea, aching, runny nose, loose stool, instantly have cold). At the time of the report, NAUSEA (nausea, aching, runny nose, loose stool, instantly have cold), PAIN (nausea, aching, runny nose, loose stool, instantly have cold), RHINORRHOEA (nausea, aching, runny nose, loose stool, instantly have cold), DIARRHOEA (nausea, aching, runny nose, loose stool, instantly have cold) and NASOPHARYNGITIS (nausea, aching, runny nose, loose stool, instantly have cold) outcome was unknown.
Day 2 - Headache and egg size reddish lump at injection site. Gone by Day 3. Day 8 - 50 cent piece size reddish lump at injection site. Warm and itchy.
Sore throat; headache; severe pain at injection site; body aches; congestion/runny nose; congestion/runny nose; fever; This is a spontaneous report from a contactable consumer (patient).  A 29-year-old female patient receive the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL3248) in the hospital, via an unspecified route of administration on 19Jan2021 at 15:15 on the left arm at a single dose for COVID-19 immunization.  Medical history included migraine with aura from an unknown date and unknown if ongoing. Concomitant medication included unspecified prenatal vitamins. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the patient experienced sore throat, headache, severe pain at injection site, body aches, congestion/runny nose and fever all on 19Jan2021 at 17:30. The patient did not receive treatment for the events. The outcome of the events was recovering. The events were reported as non-serious. The patient underwent a post vaccination COVID test via nasal swab on 21Jan2021 with a negative result.
receiving expired doses; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (receiving expired doses) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (receiving expired doses). At the time of the report, EXPIRED PRODUCT ADMINISTERED (receiving expired doses) outcome was unknown. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. It was reported that there was incident because of miscommunication as a coworker told that there were some lot number whose expirations dates have been extended. Patient received expired dose from the lot number:059H21A. No treatment medication information provided. Most recent FOLLOW-UP information incorporated above includes: On 25-Apr-2022: patient identifiers added.
Mother noticed large red circular area at immunization site when giving a bath the next night. No c/o from child, ie. itching/pain. Redness was approx. 8 cm in diameter, with darker raised area in middle two thirds of site.
skin red & swollen just below inject site; approx size 3 x 5"; pt states yesterday area had blisters, felt weak & faint; today has joint aches; pt put on Velocef;