chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PT. presented w/"scratchy" ThroaT. PT. moved To TreatmenT area where she now became dizz and lightheaded. 25mg Benadryl. PT STaTed her chesT was now "tight". HisTory + ViTals obTained. After 10-15 mins. PT. sTaTed she did noT feel any better any became more lightheaded when she Tried to sit up. EMS called and assumed care. PT. initially refused TransporT buT agreed approx. 10 mins. later sTaTing she now saw "spots" and her chest "Tightness" was moving down
p/vax pt exp pain which progressed to bilateral upper & lower weakness; seen by 3 MD; Dx: inflam arthritis was made;
vaso vagal (fainting) event immediately following injection, including jerking of the body while unconscious. lasted approx 3 mins
Information has been received from a health professional concerning a 37 month old male with a penicillin allergy resulting in hives and no other medical history who on 25-MAR-2004 was vaccinated SC with a first dose of Varivax (Oka/Merck) (lot # 647709/1247N). There was no concomitant medication. There was no illness at the time of vaccination. On 04-APR-2006 the patient experienced breakthrough varicella. He had about 15 lesions on the back of his arms and legs that were itchy. Diphenhydramine hcl (BENADRYL) was prescribed and no labs or diagnostic tests were done. The patient recovered on 14-APR-2006. Medical attention was sought and no product quality complaint was involved. Additional information has been requested.
Pt recvd vax & was found to be a nonresponder; subsequently recvd addtl 2 doses of vax; pt exp pain in hip, off & on since 2nd dose of vax;
Pt states she began having diarrhea and nausea in the evening after vaccinations. Then the next day 6/23/15 she noticed the area was red, swollen and hot to the touch. She states she has been putting ice on the area and taking Motrin. The nausea is gone but still some diarrhea. She says the area looks much better today 6/24/15.
3-18-11 client woke up with swollen facial features especially eyes and into nose area. Denies SOB; Resp. distress. No new foods. 1st ever reaction like this. BENADRYL given prior to school - encouraged to take child to medical provider.
Slight pain in left arm of injection site/Sore; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EL9262) via an unspecified route of administration, at the age of 75-year-old, administered in Arm Left on 21Jan2021 10:15 AM, as SINGLE DOSE for covid-19 immunisation.  Medical history included allergy to Penicillin and derivatives. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 and has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no concomitant medications.  The patient experienced slight pain in left arm of injection site/sore for 24hrs in 2021. The patient did not receive any treatment in response to the event. Outcome of the event was unknown.
sore arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: sore arm). The outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK receipt date: 22-Apr-2023 The case was received from the patient's wife interactive digital media. The reporter reported that the patient also got the shot and he only had sore arm. The reporter stated that make sure after you get the first dose that no longer than 6 months pass till the second dose within that time frame you must get the second one otherwise the first dose loses its strength. The follow-up could not be possible as no contact were available. The case was linked with case US2023AMR060545, reported by same reporter, for herself.; Sender's Comments:  US-GSK-US2023AMR060545:same reporter US-GSK-US2023AMR060547:deletion case US-GSK-US2023AMR060554:deletion case US-GSK-US2023AMR060545:
Infanrix to a 11 year old; 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 52m39, expiry date 25th November 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 29th September 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 29th September 2021, 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 details were provided as follows: The patient was administered Infanrix at 11 year of age, which led to  inappropriate age at vaccine administration. No further events were reported.  The reporter agreed to be contacted for follow-up.
Case number PHEH2016US023364, is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 35 years old patient of unknown gender. Past medical history and concomitant medications were not reported. The patient was vaccinated with one single dose of FLUVIRIN (batch number: 1515701) at a dose of 0.5 ml, intramuscularly, into right arm on 01 Dec 2015. On 01 Dec 2015, FLUVIRIN MDV that had been exposed to 8 to 10 temperature excursion was administered to patient. No adverse event was reported following this medication error. The case was assessed as non-serious by the nurse.
3 day following the vax pt was pale & lethargic neurologically regressed-stopped looking @ hands, pushing self up;
I RECEIVED THE FLU VACCINE ON 11/16/21 IN MY LEFT UPPER EXTREMITY AND HAVE HAD HORRIBLE PAIN , WEAKNESS EVER SINCE. I WENT TO MY PCP ON 12/7/21 (3 WEEKS AFTER FLU VACCINE) AND THE PRACTITIONER DIAGNOSED A LEFT ROTATOR CUFF INJURY. HE PRESCRIBED ME HIGH DOSE NSAIDS TO TRY FOR 2 WEEKS, IF PAIN AND LEFT SHOULDER WEAKNESS DOESN'T RESOLVE, SEE A md THAT CAN GIVE A STEROID INJECTION.
nausea x 72hr;aching joints;stated temp x 24hr;congestion;moderate to severe h/a;
Subject number: 01700084.  Initial report received on 14 May 2008 from an investigator participating in a trial under the reference number MTA37.  A 15-month-old female subject experienced a febrile seizure 93 days after receiving a second intramuscular right thigh injection of MENACTRA (lot number U2172AA) and an intramuscular left thigh injection of PREVNAR (Wyeth, lot number B53981A); vaccines were administered on 29 January 2008.  On 30 January 2008, the subject had experienced a febrile seizure, captured in case number 2008-00331.  Upon physical exam following the seizure, she was diagnosed with acute suppurative otitis media.  On 29 April 2008, the subject presented to her physician for her 15-month well-child visit.  Physical exam was within normal limits, and the subject received her fourth intramuscular left thigh dose of DAPTACEL (lot number C2800AA).  On 01 May 2008, the subject fell one step off a porch and hit her forehead.  The subject subsequently lost consciousness for approximately 20 minutes, and was transported via ambulance to the hospital.  Physical exam upon arrival noted a temperature of 100.8 degrees, and the subject was diagnosed with febrile seizure and treated with TYLENOL.  She was not admitted to the hospital.  She was seen in follow-up by her physician on 02 May 2008, and physical exam at that time was also within normal limits.  The subject was seen again by her physician on 03 May 2008, and at that time was diagnosed with "viral syndrome unspecified".  Treatment medications included TAMIFLU and AURALGAN ear drops.  Of note, the subject was a twin, and had been born prematurely.  According to the investigator, the event was related to DAPTACEL, and was not related to the study vaccine.  Documents held by sender: ER notes, office notes.
Vaccine was expired on 1Apr2022, stored in refrigerator on 4Apr2022 and administered on 19Apr2022; Expired vaccine administered to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) and PRODUCT STORAGE ERROR (Vaccine was expired on 1Apr2022, stored in refrigerator on 4Apr2022 and administered on 19Apr2022) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 19-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 1Apr2022, stored in refrigerator on 4Apr2022 and administered on 19Apr2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) and PRODUCT STORAGE ERROR (Vaccine was expired on 1Apr2022, stored in refrigerator on 4Apr2022 and administered on 19Apr2022) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant drug information was provided. It was reported that the pharmacist thought that the expiry date of the vaccine was JUNE 2022, however the vaccine expired on 01-Apr-2022. Vial was initially stored in refrigerator on 04-Apr-2022. It was confirmed that the vial had not undergone any temperature excursion issue.  No treatment drug information was provided.
Information has been received from a nurse concerning an unspecified patient of unknown age and gender. No concurrent condition, medical history and concomitant therapies were reported. On 26-JAN-2016, the patient received a dose of improperly stored oral, ROTATEQ (lot # L013197 with expire date 26-JAN-2017; dosage not reported). The temperature/time frame was Cumulative 34.1 F for 135 hours. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
I am post-menopausal and have not had a menstrual cycle since October of 2020.  I had a VERY HEAVY menstrual cycle ten days after receiving my second Moderna dose.
This spontaneous report as received from an immunization official via a company representative refers to 7 patients of unknown gender and ages. On an unknown date the patients were vaccinated with an unknown dose number of MMR II (route, dose, anatomical location and lot number unknown). The immunization official stated that she did not know if the 7 people had received MMR II in the past, concomitant medications were not reported. On an unknown date the 7 patients developed measles. The outcome of measles was unknown. Additional information is not expected.
Severe vomiting and diarrhea requiring multiple clinic visits and ER visit. Patient given ZOFRAN, oral electrolytes, and BACTRIM.
This 2 month old developed asymmetric purpuric rash on anterior shins (lower legs) bilaterally. No other symptoms. Etiology under, but rash developed 48 hours after vaccination.  Nurse follow up on 08/31/04 states: "vasculitis."
Sore arm (day 1-3), headache (day 2-3), muscle aches (day 2-3), nausea (day 2-4), fatigue (day 2-4). Aleve did not help. Symptoms abated after 4 days. No other treatment.
Pt received shot on 3/8/01 (Anthrax shot #5) and within hours, noted swelling and warmth in the area of injection (left arm) site. ^3cm X 3cm. Area slowly started to shrink but on 3/21/01 at 19:00, pt had acute swelling, papular rash in same area. He was given Ativan 25mg po X 1 with resolution of symptoms. No history of prior adverse reaction to Anthrax. He does have a history of allergic reaction to bee stings in the past.
Vomited a little bit; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Gallbladder surgery" (unspecified if ongoing); "certain food bothers her" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VOMITING (non-serious), outcome "unknown", described as "Vomited a little bit".  Additional information: Caller stated she was calling about an appointment she has this morning at 08:30 for her second Pfizer vaccine. She stated that 2 years ago she had gallbladder surgery and since then, certain foods bother her. Last night, caller clarified that it was around 1500  this morning, she vomited a little bit, but she is better now. She stated she ate graham crackers with margarine and thinks it was a little too greasy. Caller stated that she vomits about once a month since her gallbladder surgery. She is ok now and she was wondering if she can keep her appointment for today. Caller states she took the first vaccine and was fine. She reports she was fine now, she reports her appointment is at 0830 and the doctor won't be in yet that early.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Headache, Fever, NauseaVomiting, SWEATING Narrative:  Other Relevant History:
Nightmares/Night Terrors after sleeping for a couple of hours.  His friend who received the vaccine the day before had the same reaction.  Very vivid and scary dreams.
A 61 year old male received Lymerix. Reportedly, the pt was allergic to penicillin and bees. Also the pt's medical history included cervical and back problems. Reportedly on 28-APR-1999, the pt received his first dose of Lymerix. Reportedly three days later he experienced fatigue. On 28-MAY-1999, the pt received his second dose of Lymerix. Reportedly post vaccination his fatigue continued and he was found to have pernicious anemia. Reportedly, he was treated with Nascobal Nasal gel one squeeze per week and his fatigue and anemia subsequently "resolved". Reportedly, on 28-APR-2000, the pt received his third dose of Lymerix without adverse event. "Follow up labs taken on 23-AUG-2000 were all normal". As of 05-SEP-2001, the adverse event had reportedly resolved. The follow up states on 1/22/02, the responsible physician reported that the vaccinee had experienced tiredness in August 1999 which was moderate in intensity and possibly related to LYMErix. The vaccinee's vitamin B12 level in 1999 was reported aa 168pg/ml. Responsible physician stated that the vaccinee was subsequently found to have pernicious anemia.
Soreness at injection site for several days, more so than first vaccination; next day I was lightheaded; developed chills; fever of 100F; sweating; and headache all the day. Everything ameliorated by third day.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021 at 11:32 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 12-Feb-2021 at 11:32 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 73.80.  No concomitant medications were reported.  Batch number 031L20A administered on 12-Feb-2021 with temperature 35 degrees Fahrenheit from 10:00 AM to 11:00 AM. This vial was moved to fridge on 09-Feb-2021 and beyond use date for the vial was reported as 10-Mar-2021. Product moved to clinic on 12-Feb-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.
Headaches; fatigue; extreme arm Soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Headaches"; FATIGUE (non-serious), outcome "unknown", described as "fatigue"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "extreme arm Soreness". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up activities Closed : As Reporter Denied for further contact. No further information expected. (Reporter does not wish to be contacted for follow-up).
Bells Palsy; Facial weakness on right side; Headache; earache; mouth ache; runny nose; runny eye; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection) dose 2 via an unspecified route of administration, administered in Arm Left on 24Apr2021 14:30 (Lot Number: EW0171) as second dose, single for COVID-19 immunisation. The patient previously took the first dose of BNT162B2 on 03Apr2021 15:00 (Lot number: EW0151) administered to left leg for COVID-19 immunization. Medical history included high blood pressure, chronic kidney disease and diabetes mellitus. The patient has no known allergies and was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included isosorbide, metoprolol, ticagrelor (BRILINTA), clonidine and ayurvedic preparation (NEFID) all taken for an unspecified indication, start and stop date were not reported. On 01May2021 01:00, the patient experienced Bell's Palsy, facial weakness on right side, headache, earache, mouth ache, runny eye and runny nose; all on the right side. The patient did not receive treatment for the events. Since the vaccination, has the patient has not been tested for COVID-19. The outcome of the events was not recovered.   No follow-up attempts are needed. No further information is expected.
CLIENT RECEIVED J&J COVID VACCINE ON 4/8/2021 PRIFIRST PFIZER DOSE ON 8/18/2021. UNKNOWN IF CLIENT RECEIVED SECOND PFIZER DOSE.
Starting the first night after receiving the vaccine, I had a sore arm at the injection site and that is all. The next day, I felt tired but did all my normal activities. The next morning, when I woke up, I had a bad rash on the inner arm extending from the wrist to the shoulder, inner thighs from above knee to groin, trunk from abdomen to below breasts wrapping around the sides to the back and extended from underneath the inner arms to part of the chest but not all the way into the middle of the chest. The rash was bright red and almost looked like a sunburn. I took the lab request from 12/24/2021 to get the appropriate blood studies done at the height of this episode. 04/13/2022, the lab work was done and I will be following up soon with my doctor to review the results. Once the redness subsided, the itching came about (not to bad due to this being a half dose). The total episode lasted for about 5-6 days then resolved. Participant has pictures of the rashes and lab work results.
Fatigue, brain fog, sore arm, and muscle aches, joint paint, and swelling. All symptoms except joint pain and swelling resolved within a week. Joint pain and swelling have continued until this day. 9 day dose of Prednisone was administered beginning with 40mg for 3 days followed by 20mg for 3 days followed by 10 mg for 3 days. Swelling was completely gone while on 40mg and 20mg but began to return at 10 mg and has now fully returned 3 days post Prednisone. Swelling and pain continue in both knees and is progressing into hips, shoulders, and hands with swelling and weakness.
Patient is fully vaccinated as on 1/26/2021 with Pfizer and contracted COVID, tested positive on 9/10/2021.
Extreme fatigue and ache in joints.  injection site remains sore 4 days later
Developed fever several hours after injection and high fever at night (103.1 degrees).  This is second night and still has a fever of (101.7 degrees).   Body aches, sweats, and soreness.
severe swelling and redness to his left upper arm area where he received the influenza vaccine.  moderate swelling to the left upper arm with a large reddened area with a vague border.  It does not appear to be urticarial but consistent with a severe local reaction.  instructed to get vitamin C and take 10,000 mg daily in divided doses until the reaction has resolved. soak completely in an Epson salts bath with his arm submerged for about 15 minutes daily which may help.  Ibuprofen can be used for pain or discomfort.
Case number PHEH2014US002867 is an initial spontaneous report received from health care professional on 10 Feb 2014. This report refers to a 36-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1309101) intramuscularly on 15 Jan 2014. On 16 Jan 2014, she woke up with pain in her arm and had trouble in lifting her arm. It was reported that her pain continued and it was examined by a doctor. She underwent rheumatoid panel and an X-ray exam and the doctor could not find anything wrong with her. She had an excruciating pain and unable to take her clothes off due to difficulty lifting her arm. The final outcome of the events was unknown. The seriousness and causality of the events were not reported.