chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to an approximately 69 year old female patient. Current conditions and medical history was reported as none. On 21-OCT-2014, the patient was vaccinated with ZOSTAVAX, lot number K009770, expiry date 09-OCT-2015 (dose, route and frequency were not reported). Concomitant medications were reported as none. On an unknown date approximately in October 2014, the patient developed severe rash after receiving ZOSTAVAX. Patient called the pharmacy on 22-OCT-2014 and reported having severe rash. Reporting Pharmacist was not the pharmacist who actually spoke to patient about rash. No treatment was given for the rash. No lab diagnostics studies performed. The outcome severe rash was reported as not recovered. Causality assessment was not reported. Product quality complaint was not reported. Varicella Zoster Virus Identification Program (VZVIP) packet faxed to pharmacist. Additional information has been requested.
The very next day extreme exhaustion, sever headache, sore throat, stomach pain, extreme dizziness.  Pain in breast and lymph node in arm pit. This all went on for a month. I went in to get it looked at ( I could barely function at home without needing to lay down and d Nap for a month) had blood work drawn, platelets were 630. Got the second shot, got Covid arm (large, red, hot spot on arm) went back many more times. My period went on for almost 2 weeks, breast?s were over sensitive. I kept going to get checked out. Migraines were so bad and I was loosing vision, and blurred vision. Eventually I was referred to a hematologist and diagnosed with ET. A rare chronic blood cancer that normally affects older people. ( essential thrombosis) I have had 2 mini strokes since then. I felt totally normal before the vaccine. I have never felt right since the moment I got the vaccine. It triggered something. I just knew it. Even when some doctors turned me away and said it was nothing, that I was fine. I kept looking because I know my body very well. Something was off. Now I have cancer.
FREEZING COLD; FEVER; DIGESTIVE ISSUES; VOMITED; SEVERE DIARRHEA; SHAKING AND CRAZY CHILLS; SWEATING ON HER FACE DURING LUNCH; EYE ISSUE; GUM ISSUE; NOSTRIL ISSUE; FEEL SICK; VERY TIRED; MUSCLE ACHES; NAUSEA; SWOLLEN LYMPH NODES IN HER NECK; SEVERE HEADACHE; SKIN FEELS WEIRD (LIKE EEL SKIN, HEAVY AND THICK); NO APPETITE; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A and expiry: 21-SEP-2021) dose was not reported, administered on 09-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, the patient experienced eye issue. On SEP-2021, the patient experienced gum issue. On SEP-2021, the patient experienced nostril issue. On SEP-2021, the patient experienced skin feels weird (like eel skin, heavy and thick). On SEP-2021, the patient experienced no appetite. On SEP-2021, the patient experienced feel sick. On SEP-2021, the patient experienced very tired. On SEP-2021, the patient experienced muscle aches. On SEP-2021, the patient experienced nausea. On SEP-2021, the patient experienced swollen lymph nodes in her neck. On SEP-2021, the patient experienced severe headache. Treatment medications included: acetylsalicylic acid, ibuprofen, and ibuprofen/pseudoephedrine hydrochloride. On 09-SEP-2021, the patient experienced sweating on her face during lunch. On 09-SEP-2021, the patient experienced shaking and crazy chills. On 16-SEP-2021, the patient experienced digestive issues. On 16-SEP-2021, the patient experienced vomited. On 16-SEP-2021, the patient experienced severe diarrhea. On 21-SEP-2021, the patient experienced freezing cold. On 21-SEP-2021, the patient experienced fever. Laboratory data included: Body temperature (NR: not provided) 97 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from eye issue, gum issue, and nostril issue on 21-SEP-2021, and severe headache on 20-SEP-2021, had not recovered from sweating on her face during lunch, skin feels weird (like eel skin, heavy and thick), no appetite, and freezing cold, and the outcome of very tired, muscle aches, nausea, swollen lymph nodes in her neck, digestive issues, vomited, severe diarrhea, shaking and crazy chills, fever and feel sick was not reported. This report was non-serious.
On day 9 after receiving the first dose of Moderna Vaccine I developed a large red rash approx. 2" X 4" (HXW). The rash was warm to touch and very itchy. The rash was hard and red. It felt sensitive and uncomfortable. The rash lasted thru day 16 and dissipated. During the rash I took Benedryl and Ibuprofin.
Arthralgia Narrative: Joint pain- all joints, severe after second dose. First dose 12/17/20, same reaction, but not severe
a box / was left with 2 vials of antigen /believes the adjuvant portion was only administered; a box / was left with 2 vials of antigen /believes the adjuvant portion was only administered; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 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 details were provided as follows: The age group was not reported, however it was captured as an adult as per vaccine indication. The age at vaccination was not reported. The reporter during monthly inventory found out that a box of Shingrix was left with 2 vials of antigen and believed that the adjuvant portion was only administered to the patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter asked if to revaccinate the patient. No other details of patient, vaccine or date was available. The reporter consented to follow up. This case has been linked with US2021AMR084838 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR084838:same reporter
Began having extreme itching left upper arm and, upon inspection, noticed large red rash.  This rash and itchng continued for approx 1 week
accidentally received a dose of Infanrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 11-year-old female patient who received DTPa (Infanrix) (batch number 23T73, expiry date 30th April 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 07-Apr-2022 Reporter's Comments: The reporter stated that the patient accidentally received a dose of Infanrix, Infanrix was indicated for active immunization against diphtheria, tetanus, and pertussis as a 5-dose series in infants and children aged 6 weeks through 6 years (prior to the 7th birthday).  The reporter consented to follow up. Additional Supportive Information: The patient accidentally received a dose of Infanrix, which led to inappropriate age at vaccine administration.
Site: Redness at Injection Site-Mild, Additional Details: Patient said the following day, noticed a warm, red, achiness radiating upwards from injection site. symptoms common with Covid Arm, rph suggested using a cold compress and tylenol and to follow up with MD if symptoms get worse
On January 18th in the afternoon my head started itching. The following day on January 19th my entire body started itching. I took Benadryl and it caused the itching to stop. The next day on January 20th the same thing happened so I took another Benadryl. I went to see a doctor on January 21st. The doctor attributed my itching to the vaccine. I have been taking an antihistamine since then called Allegra.
Modern Vaccine I felt a little nervous but I?m not afraid of vaccines. Arm hurt, got home was more shaken inside. Took Ibprophen for pain. I continued to feel hyper, then tired, repeatedly all day long. At some point I remember feeling like my breathing was way too fast. The nervousness became fretfulness. At bedtime, I took my normal medicine and 3 mg of Melatonin as usual. I could not stay rested. My body would do one jerk and wake me. I finally got up to read and took .025 mg of Clazonapem . I have that for flying, etc.  Today, March 11, 2021 I awoke at 6:30 am feeling much better but then as the day has continued I am out of sorts. Everything is very difficult to think about doing. My brain is getting stopped from simple writing ABC?s on index cards. Questions are overwhelming me. I?m not sure if I should even consider the second vaccine. This is very unsettling as I am normally very functioning as  a teacher, artist, homemaker. Caring on a conversation is troubling.
Information has been received from a healthcare worker (medical assistant) referring to a patient of unknown age and gender. Information about patient's concurrent conditions and medical history was not reported. On 21-SEP-2015 the patient was vaccinated with a dose of VARIVAX (Merck) (dose and route not reported, lot # L015046 with expiration date 29-APR-2017) that had been improperly stored. Concomitant medications were not provided. No adverse effects were reported. This is one of two reports received from the same reporter (other linked case # 1510USA006858). Additional information has been requested.
Pain at the injection site. The pain became worse several hours later and my arm was sore and achy. I was sore for a couple of days and it never went away. It just felt like something didn't need to be there but was there. I felt it every time I moved my arm. I couldn't lift anything beyond 10lbs without having pain. i didn't seek treatment but the pain never went away.
This is a spontaneous report from a contactable consumer (patient). A 24-year-old (non-pregnant) female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# not reported), at the vaccination age 24, via an unspecified route of administration, on an unspecified date, in Mar 2021, single dose, for COVID-19 immunisation. Medical history: none. There were no concomitant medications. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, patient was not diagnosed with COVID-19. Reportedly, she always had her period on time. She was never late. On an unspecified date, patient was 3 days late and her period was very light. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether therapeutic measures were taken for the events. On an unspecified date in Apr 2021, patient underwent lab tests and procedures, which included nasal swab resulted as negative. The outcomes of reported events: unknown (at the time of reporting). The lot number for the vaccine BNT162B2 was not provided and will be requested during follow-up.
sick; have symptoms of covid-19 was tested on 3 Apr 2021 and received positive results for Covid 19; her husband all of a sudden coughed up a bunch of gunk, but he was not congested; Headache/ his head still hurts/headache; Low grade fever; her husband was really tired; This is a spontaneous report from a contactable consumer or other non hcp. A 50-years-old male patient received bnt162b2 first dose of (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 28Mar2021 as single dose for covid-19 immunization. Medical history included ongoing hypertension, blood cholesterol increased, body mass index increased from an unknown date and unknown if ongoing. There were no concomitant medications. The patient experienced have symptoms of covid-19 was tested on 03Apr2021 and received positive results for COVID-19. Also reported headache/his head still hurts on, low grade fever, tired on 30Mar2021. It was reported her husband got all of sudden coughed up a bunch of gunk, but he was not congested on 02Apr2021 and sick on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test as negative on 29Mar2021, sars-cov-2 test as positive on 03Apr2021. She said her husband would really like to have the second COVID-19 Vaccine for protection against the COVID-19 Virus. Treatment as reported her husband took Mucinex, Ibuprofen, and drank a lot of tea with honey in it. She said her husband had the Mucinex and Ibuprofen with him in isolation, so she couldn't provide the NDC, Lot, and Expiration Dates. She clarified her husband took generic brand Ibuprofen, and Mucinex. She said her husband had been on a statin for a while. She said the only other medicine her husband took was Vyvanse, and he had been on Vyvanse forever. She said her husband had a second COVID-19 Virus test on 03Apr2021, and he was told on 04Apr2021 that he was positive for the COVID-19 Virus. She said her husband had his temperature checked on Saturday (03Apr2021) and it was 98.5 degrees. She said when her husband got home last night (05Apr2021), he had a fever of 101 degrees. She said her husband had been sleeping since. The outcome of the event was unknown for cough and illness and not recovered for the other events.  No follow-up attempts are needed. Information about lot/Batch number cannot be obtained.
headache; nausea; chills; body ache; This is a spontaneous report received from a contactable consumer. A 65-year-old female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EM9810), via an unspecified route of administration, administered in left arm on an unspecified date as second dose single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 for Covid-19 immunization and experienced soreness in arm and took Ibuprofen. After second dose the patient experienced headache, nausea, chills, body ache on 21Feb2021. Patient did not received treatment for the events. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Bad side effect in her lymph node right now; Little bit of sore in her arm; This is a spontaneous report from a Pfizer . A contactable consumer (patient) reported that a female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date not provided), via an unspecified route of administration, on 16Apr2021, at single dose, for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date not provided), via an unspecified route of administration, on unspecified date, at single dose, for COVID-19 immunization. The patient had had the 2nd shot of the vaccine on 16Apr2021. She was experiencing bad side effect in her lymph node right now but she did not stated the exact side effect. Also, patient stated that she had a little bit of sore in her arm. Other than these she did not have any symptoms. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt was vaccinated with 50 units instead of 25 units of hepatitis a virus vaccine.  Subsequently the pt experienced GI upset with diarrhea and decreased appetite for two weeks.  Pt also had red eyes. At the time of this report the pt had recovered from the diarrhea and red eyes but her decreased appetite "picky eating" perissted. Additional information has been requested.
bleeding heavy; my menstrual cycle came early; booster; This is a spontaneous report from a contactable other HCP.     A 26-years-old female Non pregnant patient received bnt162b2 (BNT162B2 PFIZER BIOTECH MRNA COVID 19 SOLUTION FOR INJECTION, (Batch/Lot Number: EW0172), dose 3 via an unspecified route of administration, administered in Arm Left on 03Nov2021 13:00 as dose 3 (booster), single for covid-19 immunisation. Medical history included hypertension, food allergy. Concomitant medication(s) included lisdexamfetamine mesilate (VYVANSE); hydrochlorothiazide (HYDROCHLOROTHIAZIDE); lamotrigine (LAMICTAL); buspirone hydrochloride (BUSPAR). patient previously took bnt162b2 for covid-19 immunisation, bnt162b2 for covid-19 immunisation, phenergan [promethazine] and experienced drug hypersensitivity. Patient was not Pregnant at the time of vaccination. The patient had not received any other vaccine within 4 weeks, Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination patient receive other medications the patient received within 2 weeks of vaccination:Vyvanse, hydroclothized, lamictal, buspar.It was Reported that, The patient experienced booster on 03Nov2021 13:00 with outcome of unknown, bleeding heavy, my menstrual cycle came early on 05Nov2021 07:45 with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 29Sep2021 Nasal Swab.  Follow-Up (10Nov2021): Follow-up attempts are completed. No further information is expected.
Information has been received from a registered nurse concerning multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not reported. On unknown dates, the patients were vaccinated improperly stored ROTATEQ (lot # M025568 with expiration date 07-NOV-2017; dose and route were unknown). The vaccines were exposed to temperature excursion of minimum (Min) -0.5 degrees centigrade for 3 hours 39 minutes and maximum (Max) 15.9 degrees centigrade for 16 minutes on 28-SEP-2016; Min 0.8 degrees centigrade for 5 hours 19 minutes on 29-SEP-2016; Min 0.7 degrees centigrade for 5 hours 37 minutes on 30-SEP-2016 and Min 1 degrees centigrade for 2 hours 26 minutes on 01-OCT-2016. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
pt recvd vax & was drowsy; taken to exam rm; recovered full consciousness; BP 100/80;
little bit fever and chills at night; little bit fever and chills at night; This is a spontaneous report from a contactable consumer (patient). This consumer reported events for 3 patients. This is the 2nd of 3 reports. This female consumer reported for herself that: A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date, the patient experienced little bit fever and chills at night. The outcome of the events was reported as resolved on an unknown date.  Information about lot/batch number has been requested.
Abrupt onset of red rash Friday afternoon with lumpy sacs. Itchy, sting-y, burn-y, non-stop. Treated with Triamcinolone Acetonide 0.1% ointment. By Saturday (5/1), rash was every where and unbearable. Called Dr, he ordered Rx Prednisone, 10mg Tabs and Benadryl, 25mg Tabs - 10-day regimen. No fever at any time.
This report was received from a registered nurse refers to a male patient of unknown age who was in a non-Merck investigator-initiated study. On an unspecified date, in August 2012, the patient was vaccinated with a dose of GARDASIL (lot number 660393/0067X) (dose and route not reported) that was expired 20-OCT-2012. No adverse effects had been observed or reported. Due to the nature of the study, the reporter declined to provided any patient identifiers. She would like to know if the patent should be revaccinated. Reporter called back on 16-OCT-2012 to stated that there was no additional information to provide, and she was not comfortable faxing these forms back. She requested that no additional follow-up forms or letters were sent to the office of this matter. This is one of several reports that received from the same source. Additional information is not expected.
3-4 minutes after receiving injection patient's caregiver noticed some swelling of patient's left eye. Patient did not complain of any shortness of breath, itching, hives, etc. BP and pulse ox were normal, but some wheezing was noted by a physician in the vaccine clinic. Patient was transferred to our ED for further evaluation. The ED did not hear any wheezing, and the patient's caregiver said that the swelling of her eye appeared to lessen. She was treated in the ED with IV Benadryl, Solu-Medrol, and Pepcid. Was discharged approximately 2 hours later.
PT MOM CALLED DAY AFTER SHOTS WERE GIVEN & INFORMED US THAT HER SON HAD PERSISTENT CRY >3 HOURS & FEVER>103* & TYLENOL NOT BRINGING TEMP DOWN. ADVISED THEM TO GO TO ER SINCE THEY WERE @ HOSPITAL ALREADY WITH FAMILY MEMBER.  9/21/06 Received medical records from hospital which reveal patient admitted 8/11/06 w/bronchiolitis w/respiratory distress & subcostal retraction.  Presented w/runny nose, rapid breathing & significant cough.  Seen by PCP but continued to worsen prior to hospitalization.  D/C to home on 8/13/06 w/neb treatments. No PMH & no ill family members.    Patient was readmitted to hospital 8/22/06 w/fever & poor oral intake, possibly viral infection.  Initial WBC 15,000. Cultures neg & d/c home 8/24/06. No PMH & no ill family members. Birth records also included which reveal patient was NSVD & only problem was neonatal hyperbilirubinemia & was rehospitalized for that for overnight observation & phototherapy/ss
Total deaf left ear, taking steroids by pill and injection audiologist, ear nose and throat.  No resolution, may take 6 weeks to one year to possibly regain some hearing.