chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain and swelling at the injection location.  Extreme tiredness, headache, muscle pain/soreness, chills and intermittent  (minimal) nausea.  Felt like my body was working harder than normal, with slight tightness in my chest.
Patient's wife called to report pt. had hives all over his body.  Not blistering or oozing.  We recommended that he notify his provider and go to an urgent care.
A report has been received from a Health Professional concerning a 2  year old, male subject, who had been receiving nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent started on 08-NOV-2014.  The patient experienced multiple patients received FLUMIST Quadrivalent and tested positive for flu A which started on 25-NOV-2014. The outcome of the event of multiple patients received FLUMIST Quadrivalent and tested positive for Fly A is unknown. The report was considered to be non-serious.
Patient found a supraclavicular mass about 6 days after receiving vaccination. The lymph node was about 1 cm in size, firm and fixed. Given the concerning location of the supraclavicular node, labwork was performed and chest X-Ray was done. All labwork and X-Ray findings were reassuring. Patient was scheduled with otolaryngology for evaluation and possible biopsy, but lymph node had improved in size on the morning of 8/7, so further evaluation was postponed. By the morning of 8/9, the lymph node had almost completely resolved.
Had to reschedule second Moderna dose for 4-5-2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Had to reschedule second Moderna dose for 4-5-2021) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Had to reschedule second Moderna dose for 4-5-2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Had to reschedule second Moderna dose for 4-5-2021) had resolved.            Concomitant product use included migraine medications and Birth control.  Treatment of this event was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Follow up information was received on 15-Jun-2021 and contains no new information.
Information has been received from a medical assistant concerning a 15 year old female with no previous medical history or drug allergies reported who on 17-DEC-2008 was vaccinated with the first dose of GARDASIL (Lot # 661044/0548X), 0.5 mL, I.M. On around 05-JAN-2009, the patient became really sick, had a fever of 104 F, a sore throat, and was dehydrated. The patient was awakened in the middle if the night but was not fully alert. Her mother, who spoke with her that night, said that she did not know where she was. On 05-JAN-2009, the patient was taken to the emergency room. She was given MOTRIN and IV fluids. The emergency room could not find a cause for her illness. On 17-FEB-2009, the symptoms were resolved. The patient was followed up on 21-FEB-2009 by her primary care. The symptoms were considered to be an other important medical events by the medical assistant. Additional information has been requested.
Erythema multiforme rash on trunk, began 11/24/2003.  Prescribed Benadryl 1.2-1 tsp every 4 hours as needed.
PATIENT RECEIVED A DOSE OF PFIZER BIVALENT BOOSTER DOSE WAS PAST BUD, SPOKE TO PATIENT AND SHE STATED HAS NOT EXPERIENCING ANY ADVERSE EVENTS. PATIENT WILL SCHEDULE TO BE RE-VACCINATED NEXT WEEK (AT LEAST 8 WEEKS APART PER CDC GUIDELINES)
13 year old patient received Infanrix instead of Boostrix; 12 year old patient received Infanrix instead of Boostrix; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 12-year-old female patient who received DTPa (Infanrix) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 18th March 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 18th March 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter only provided patient's demographics. The reporter reported that the 12 years old patient received Infanrix instead of Boostrix, which led to wrong vaccine administered and inappropriate age at vaccine administration. The reporter did not have lot number neither expiration date of Infanrix.  The reporter consented to follow up.
vials were stored in the refrigerator and thawed on same day of administration; Vacccine was expired on 04-Apr-2022 and was administered on 20-May-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (vials were stored in the refrigerator and thawed on same day of administration) and EXPIRED PRODUCT ADMINISTERED (Vacccine was expired on 04-Apr-2022 and was administered on 20-May-2022) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vacccine was expired on 04-Apr-2022 and was administered on 20-May-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vials were stored in the refrigerator and thawed on same day of administration). At the time of the report, PRODUCT STORAGE ERROR (vials were stored in the refrigerator and thawed on same day of administration) and EXPIRED PRODUCT ADMINISTERED (Vacccine was expired on 04-Apr-2022 and was administered on 20-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient weight was reported as 180. Patient received Booster 2. No concomitant medications were reported. It was reported that the Vials was thawed on the same day of vaccine administration date. Vials did not  undergo any temperature excursions. No treatment information were reported.
Diarrhea; Weakness; Muscle pain; Shivering; Headache; This case was reported by a consumer via call center representative and described the occurrence of weakness in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th November 2020, the patient received the 2nd dose of Shingrix. On 11th November 2020, less than a day after receiving Shingrix, the patient experienced weakness, muscle pain, shivering and headache. On 12th November 2020, the patient experienced diarrhea. On an unknown date, the outcome of the weakness, muscle pain, shivering, headache and diarrhea were unknown.   It was unknown if the reporter considered the weakness, muscle pain, shivering, headache and diarrhea to be related to Shingrix.  Additional information was provided as follows: The patient experienced weakness, muscle pain, shivering, headache and diarrhea after receiving the 2nd dose of Shingrix. No additional information was provided. The reporter consented to follow up.
Patient was accidentally given a COVID-19 vaccine (orange cap, ages 5-11yr) outside of 12-month expiry date. Lot #FL2757 Mfg date: 10/2021 Exp date: 9/30/2022
The first shot was on 10Mar2021 and my second shot was on 01May2021; The first shot was on 10Mar2021 and my second shot was on 01May2021; Got rash on my body, both sides, waist, above ribs and calves; it is getting dry and itching; Got rash on my body, both sides, waist, above ribs and calves; it is getting dry and itching; Got rash on my body, both sides, waist, above ribs and calves; it is getting dry and itching; Fever; Chills; This is a spontaneous report from a contactable consumer. A 42-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: ER8737, Expiration Date: Unknown) via an unspecified route of administration, administered in left arm on 01May2021 (at the age of 42-year-old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 10Mar2021 as dose 1, single for COVID-19 immunization. The first shot was on 10Mar2021, and his second shot was on 01May2021 (Off label use, inappropriate schedule of vaccine administered). On an unspecified date in May2021, patient stated, he had little rash on his body after his vaccine next day. It gave him fever, chills, got rash on body like his both sides, (his waist also), above his ribs and also on calves but asked he knew how long it was going to take to be gone. Patient asked what the best advice was, to use some cream or take some medicine. He was not quite sure which one is the best. He was just itching. Patient was using body lotion cream. Outcome of all events was unknown. No follow-up attempts are possible. No further information is expected.
Presented with weakness, fever, chest congestion; Covid + PTA at PCP office; admitted with Covid PNA to facility; tx with supplemental O2, maxipime, remdesivir, zinc, zithromax, baricitinib, rocephin,  steroids, actemra; intially with LF NC and went to HF NC O2;was back to 2L O2 at time of dc;
received Rotarix second dose IM; This case was reported by a nurse via call center representative and described the occurrence of inappropriate route of vaccination in a 4-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number AB3BR, expiry date 29th June 2023) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 23rd November 2021, the patient received the 2nd dose of Rotarix lyophilized formulation (intramuscular) and Rotarix Oral Applicator Device. On 23rd November 2021, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced inappropriate route of vaccination. On an unknown date, the outcome of the inappropriate route of vaccination 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 details were reported as follows: A nurse reported that, the patient received Rotarix 2nd dose intramuscular route by error, which led to inappropriate route of vaccination. The reporter also said that please call health care professional before sending the form to confirm address. The reporter consented to follow up. The case had been linked with US2021241785 (twins) reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021241785:same reporter
8 days after vaccine developed redness, itching, warmth, and swelling at vaccination site. Rash continued to grow for 48 hours in an oval shape over deltoid area - largest measurements 7"long x 5"wide. Now starting to decrease (on day 10 after vaccination). No fever at any point.
Initial cellulitis around site and fever, ED visit, sent home with Keflex.  Came back in to ED wtih cellulitis at vaccine site in right upper arm and septic shock.  Admitted to ICU for treatment.   Recovered sent to floor.  Recovered.
Muscle/tendon aches in the ankles and wrists, hive-like rash on left wrist, swollen lymph node near injection site, flu-like symptoms.  Doctor described it as a 'viral response.'
This spontaneous report was received from a pharmacist via a field representative regarding a 60 year old female patient. No historical or concurrent conditions were reported. On approximately 08-OCT-2015 ("about two weeks ago"), the patient was vaccinated with ZOSTAVAX subcutaneously (lot# unspecified). No concomitant medications were reported. On approximately 10-OCT-2015 ("Two days after receiving the injection"), the patient reported back to the pharmacist with complaints of redness and swelling at the injection site. The pharmacist stated the injection site was "warm to the touch". The patient sought medical attention - returned to the pharmacy. The pharmacist recommended BENADRYL and TYLENOL. No Product Quality Issue (PQC) was reported. The outcome of the events were unknown. Causality assessment was not provided. No additional information was provided. Additional information has been requested.
About 10 minutes after receiving COVID vaccine, patient became lightheaded and nauseated. He states that he thinks he may have passed out because he was laying on the exam table. He tells this nurse that he has a history of becoming anxious and having nausea/lightheadedness and then passing out. He hasn't eaten anything today and didn't sleep well last night. He did drink some coffee this morning. He is pale. Vital signs: 98.0, 85, 99%, 130/81, 18. Patient did vomit small amount of brown colored liquid emesis and then states that he is feeling better. He was given water and a snack. Per doctor, patient was monitored for another 15 minutes. Patient states that he is feeling ok and he does not wish to be seen in urgent care at this time. He will return to clinic or ER as needed.
I fully support efforts to end this COVID-19 pandemic. That is why I took these vaccinations  Over the last twenty years I have taken a number of vaccination including an annual seasonal flu shot. I have learned during these years that when I take such a vaccination I need to do it when my schedule is clear to allow for several days of down time. I usually need several days to recover from such a vaccination. I also take only one vaccination at a time to lessen any problems I may have with it. Sometimes I have had a large red spot on my vaccination arm, up to four inches wide, near or around the injection site.  Continued:
pt recv vax 29AUG96 & 6SEP96 & pt devel a fever 105 & a rash;
Pt had a reported history of feeling dizzy and vomiting after vaccination.  The patient was nervous and anxious for the vaccination and was being held by her father.  After the vaccine was given the pt experienced vasovagal syncope and briefly lost consciousness in her fathers arms and urinated. The pt quickly regained consciousness. the pt was observed for approximately 5 min. and it was suggested she stay for 15 minutes but she appeared to be fine and the parents decided against staying.
Patient received Moderna for series 1 and 2, and then received a Pfizer brand for the 3rd/booster series. No adverse events reported by patient as of 10/19/21.
I started feeling really tuff like I was going to get sick. The same way I felt when I had the flu. Arms and legs hurt up and down . Then I started getting cold like you do when you have a fever. It was weird feeling.  I was so so cold that I was shaking violently.  I had to put lots of clothes on and get under the blankets and once even turning on hair dryer to get warmth. .  I had three episodes of the same violent shaking thing. Once on Friday eve and twice on Saturday.  I did not take my temperature because it didn't seem to be the same.  However when got up to go to RR and returned back down it felt like I could feel the heat coming off my head. I was that hot.  This isSunday and I am ok now but wanted to report this and I wasn't expecting this at all.  I have not had Covid at all thank God. I did not call the doc because I knew some people have symptoms but didn't expect the fever kind of thing if the virus is dead.
This spontaneous report was received from an unspecified reporter via an online post that refers to an unspecified number patients of female patients of unknown age. Information regarding the patients' medical history and current condition were not provided. The online article states that patients were vaccinated with GARDASIL and then developed chronic health problems (adverse event), several hundred young women had died and thousands more were permanently disabled. There were cases of sudden death following the vaccination. Syncope was also mentioned to be the most common adverse reaction after use of GARDASIL. The outcome of the adverse event, disability and syncope was unknown. The causality assessment was not provided. Upon internal review, sudden death and disability was considered to be medically significant. Permanent disability was considered to have caused significant incapacity/disability. The case is linked to 1605USA011079 (same reporter link). Additional information has been requested.
the right side of my neck swelled up; I could not speak or think properly; I could not speak or think properly; blood pressure was 177 over 80 and kept going up/got to 205 over 100 and they took me to the hospital and it took 3 hours for it to get to a reasonable number of 149 over 80/blood pressure this high; feeling bad; This is a spontaneous report from a contactable consumer (patient). A 52-year-old non-pregnant female patient received the dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: er2613), via an unspecified route of administration on 23Mar2021 12:15 (at the age of 52-years-old) at dose number unknown, single in the left arm for COVID-19 immunisation. Medical history included corn allergy and asthma. The patient was allergic to lots of products in the store. The patient has a safe list from her dermatologist so she knows what kind of shampoo, clothes detergent, etc. she can buy. The patient had no COVID prior vaccination, was not tested for COVID post-vaccination, and was not pregnant at the time of vaccination. Concomitant medications included losartan and citalopram. The patient previously took lisinopril, lactose, and ammonia, and experienced allergies. The patient was vaccinated in a public health department. On 23Mar2021 12:15, the patient started feeling bad immediately. The patient stated, " they asked me to back up and I went left and ran over an orange cone that got stuck under my Prius because I misunderstood them". On 23Mar2021 12:15, the patient's blood pressure was 177/80 and kept going up. The patient's blood pressure got up to 205/100. The patient was brought to the hospital on 23Mar2021 and it took 3 hours for it to get to a reasonable number of 149/80 so the patient could go home. The patient never had her blood pressure this high. The patient was not anxious about getting the shot at all and felt normal before hand and these all happened very quickly. The patient will not get the second dose because she doesn't want to have a stroke. The next morning, on 24Mar2021, the patient's right side of her neck swelled up and she could not speak or think properly. It was reported that the events resulted in emergency room/department or urgent care visit. It was unknown if patient was given treatment for the events. Outcome of the events blood pressure high was recovered on 23Mar2021, and for other events was recovered on an unspecified date in 2021.  Follow-Up (22Jul2021): Follow-up attempts are completed. No further information is expected.
arm pain; light headedness; abdominal pain; swollen, tender lymph node left axillary area; swollen, tender lymph node left axillary area; This is a spontaneous report from a contactable nurse (patient). A 60-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE; lot number: EK4176; expiration date: unknown), via an unspecified route of administration left arm on 08Jan2021 08:30 at a single dose for covid-19 immunization. The patient medical history was not reported. The patient has no known allergies. There were no concomitant medications. The patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE; lot number: EK5730; expiration date: unknown), via an unspecified route of administration left arm on 18Dec2020 10:30 at a single dose for covid-19 immunization. The patient experienced arm pain, light headedness, abdominal pain and swollen, tender lymph node left axillary area on 08Jan2021 04:00 PM. The patient received treatment for the adverse events includes acetaminophen (TYLENOL) and ibuprofen (MOTRIN). The outcome of the events was recovered on in Jan2021.
Swelling and pain around injection site 2 1/2 inch (6.35 cm) diameter; Swelling and pain around injection site 2 1/2 inch (6.35 cm) diameter; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 at 17:00 as dose 1, single (Lot number: GJ3277) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic leg pain" (unspecified if ongoing). Concomitant medication(s) included: FLUCELVAX QUAD taken for immunisation, on 26Sep2022 as dose 1, single. Past drug history included: Benadryl, reaction(s): "Known allergies: Benadryl". The following information was reported: VACCINATION SITE SWELLING (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 05Oct2022, outcome "unknown" and all described as "Swelling and pain around injection site 2 1/2 inch (6.35 cm) diameter". Therapeutic measures were taken as a result of vaccination site swelling, vaccination site pain.  Additional information: the patient's adverse effects were treated with applying ice on the area. She had no COVID prior to vaccination. She was not tested for COVID post vaccination.  No follow-up attempts are possible. No further information is expected.
Low grade fever, body aches, fatigue, rash on arm, generally poor feeling. All except rash  resolved on 2nd day after vaccination.
Headache SWELLING, PAIN IN CHEST UPPER BACK, RIGHT ARM, CHILLS  Narrative:   Other Relevant History: