chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I hurt all over; Nausea; I feel feverish; Headache; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 31-MAR-2023, the patient received Shingles vaccine. On 31-MAR-2023, less than a day after receiving Shingles vaccine, the patient experienced pain (Verbatim: I hurt all over), nausea (Verbatim: Nausea), fever (Verbatim: I feel feverish) and headache (Verbatim: Headache). The outcome of the pain, nausea, fever and headache were not resolved.   It was unknown if the reporter considered the pain, nausea, fever and headache to be related to Shingles vaccine.     It was unknown if the company considered the pain, nausea, fever and headache to be related to Shingles vaccine.   Additional Information: GSK receipt date: 31-MAR-2023 The case was received from the patient interactive digital media. The patient just got the first shot on the day of reporting and he/she stated that it hurt all over, nausea and felt feverish and headache also. The follow-up could not be possible as no contact details were available.
Local reaction where VARIVAX immunization administered 5 x 5.4 cm area-red, raised and pruritic/painful afebrile; no systemic symptoms. Treated with BENADRYL and cool compresses. Symptoms resolved after a few days
administration of an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 31-year-old female patient who received HAV (Havrix) (batch number 7YA99, expiry date 30th September 2022) for prophylaxis.   On 4th October 2022, the patient received Havrix. On 4th October 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 04-OCT-2022 Reporter's Comment: The nurse asked and reported that a dose of Havrix given to the patient and it was already expired.  The reporter asked if the patient had to be re-vaccinated. The reporter did not consent to follow up.  Additional Supportive Information: The use of Havrix dose, which was already expired on 30th September 2022, which led to expired vaccine used.
The 10 year old girl is losing patches of her hair.  This started after her 2nd Covid Vaccination.  Every few days more patches of hair are missing on her head.  Each patch of missing hair seems to be getting larger.
69 expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (69 expired doses administered). On 06-Jan-2022, EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  On 06-Dec-2021, the vials were placed in refrigerator.  No treatment information was provided by the reporter.
Hours after injection  (Saturday) my neck and head started aching.  The next 2 days (Sunday and Monday) I had muscle aches, chills, diarrhea and a headache.  The 3rd day  (Tuesday) I still had a dull headache but no other symptoms.  Fourth day; back to normal.
This is a spontaneous case, initially received on 20-Dec-2017 reported by a pharmacist concerning a male patient of unspecified age. It was reported that, the patient had never experienced any reactions to his past influenza vaccines. The patient's concomitant medication included: Naproxen, AMBIEN, Lorazepam, Lisinopril, Bupropion and Duloxetine for an unknown indication. On an unspecified date, the patient was administered with AFLURIA (TIV) (dose: 0.5ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: XF30029, expiry date: not reported). On an unspecified date, after the administration of vaccine, the patient felt hot, confused and tired. At the time of this report, the outcome of the events was not reported. The reporter assessed this case as non-serious. Significant case correction was received on IRD 20-Dec-2017: The causality of the events (tiredness, confused and feeling hot) was changed from unassessable to related. No changes were done in narrative.
12 hrs after shingles shot terrific pain in one eye woke me. Next day had double vision, nausea, balance, headache. Eye lid closed in 7 days. All Dr tests and scans did not detect any problem. Little pain sine Jun 23rd. Tried to sleep in lounge chair 17 nights (3-4) hrs ea night. Merck and Co. mfg. No vac. with in 1 wks. Eye lid still closed.
Administered expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) in a 71-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported  The pharmacist reported about the administration of expired Moderna vaccine that were given as booster shot to the patients around 490 to 500 on the last date 20-OCT-2021 to 29-NOV-2021. The Lot number of vaccines were as 006C21A (10-OCT-2021), 026B21A (17-SEP-2021), 031B21A (22-SEP-2021). It was reported that the vaccines was stored in freezer,  took out one to two vials and place in fridge each day as needed.  No treatment was provided to the patient.
25 year old male with history of allergic reaction one week after receiving anthrax vaccines. He has received a total of 8 vaccinations starting in 1999. With every vaccination, he was worsening symptoms such as eye swelling, tongue swelling, hand swelling, hives. No broncho-constriction. He is due for deployment in Jan 05. He is due for another anthrax booster.
Patient stated he woke up at 4:30am on 4/11/18 not feeling well. He began to ache and hurt all over, especially his joints and muscles. He couldn't hardly move. The following on 4/12/2018, his stomach began hurting and having diarrhea. On Friday 4/13/18 his soreness has been noticably less. His stomach has continued to hurt and have diarrhea. He has been taking pepto for his stomach. He did take 2 extra strength acetaminophen 500mg tabs on 4/12 and 4/13.
24 hours after receiving the second vaccine, I developed fevers, headaches, chills, exhaustion and tachycardia.  All symptoms improved within 4 days. However, the tachycardia has persisted.  I am experiencing postural tachycardia. When sitting my HR is 80s to 90s, upon standing my heart rate increases to 120s-130s. Currently I am under the care of a cardiologist.  She is unsure if the tachycardia is due to the vaccine or if it triggered something that was underlying.  Plan to increase my fluids, wear compression stockings, and follow up in 3 months.
79-year-old male admitted 5/13 for altered mental status, with shortness of breath. Per report, patient's wife recently diagnosed with COVID. Found to be positive for COVID-19 on 5/13.  D-dimer elevated.  Given CKD, he could not get a CTA chest hence a VQ scan was ordered which showed possible pulmonary embolism.  He was started on heparin infusion, hematology consulted.  Discharged on an appropriate dose of p.o. Eliquis with outpatient follow-up.  Discharged 5/17 with home health care in stable condition, follow-up instructions provided. All questions and concerns were answered and addressed prior to discharge with patient/family.  Prescriptions were provided.
I am in menopause, 19 days after the shot I started bleeding and it is VERY heavy. I am still bleeding and it?s been 7 days still heavy as well.  I called the dr  on Thursday, April 29 and she set up an ultra sound , but I didn?t even mention to her that I had a shot because I hadn?t heard about this happening until I had already spoke with the dr. Also very tired but I think that?s from bleeding so much. Not sure if there?s any way to know for sure if it was caused by the shot but if they do t find anything else wrong with me I?m going to assume it?s from the shot since it seems to be happening to a lot of women
Fever, chills, nausea, headache, muscle aches, arm pain and swelling, fatigue,
Severe swelling, pain, redness and warmth at vaccination site.  Treated with NSAIDs, APAP, movement and heat
Irregular menstrual bleeding- after my normal bleeding ends, a day or two later I start spotting again. Ranges from a day or two of spotting to a week of heavily clotted bleeding.
Pt recvd vax on 17MAY93 & was found to have devel Hep B; signs & sx included elevated liver function tests, itching, dark urine, & pos Hep B core antibody;
2 hours after administration, patient experienced dizziness, weakness, low BP, and dehydration resulting in visit to emergency room.
It may my life very hard/I had a hard time making friends/I could not play sports/ I could not attend to regular school; It made me worry about forever/It made me worry about the world collapsing; I have a hard time talking; I had to be careful of what I ate; This spontaneous report was received from the patient's mother referring to a 1-year-old male. The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On an unknown date in 2003 (reported as "when I was one"), the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (dosage regimen, lot #, expiry date, and route of administration were not provided), administered as prophylaxis.  Since an unspecified date in 2003, the patient reported that was injured by the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) vaccine. He stated that made his life very hard, he had a hard time making friends, and could not attend regular school and not play sports (Unevaluable event). The vaccine made him me worry about forever, worry about the world collapsing (Anxiety). Also, he reported that had a hard time talking (Speech disorder) and he had to be careful of what he ate (Eating disorder). The patient saw a lots of doctors over the years to try to help him be healthier. At the time of the report, the outcome of the event were not provided.  The causal relationship all reported events and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was unknown.
Given 0.5mL of Hep A instead of the full. Called patient to come in. Gave the full amount needed. She should be okay.
Patient received influenza vaccine IM in left arm on 09/30/09.  Parent noted redness on left upper arm on 10/02/09.  Seen in office 10/02/09 with large area of redness and tenderness involving 90% of anterior upper left arm.
Two hours after vaccination child had fevers up to 102.8.  Fever lasted a couple of days.  Red rash and lasted 3 to 4 days.  Rash came and went all over body and resulted in ER visit.  Child was started on 10 day course of amoxicillian for bilat ear infections.  No resp problems, no N/V/D.  Child is whinny
SWOLLEN LYMPH NODE PAINFUL TO TOUCH,(UNDER ARMPIT, SPREADING TO CHEST)
Severe lower and mid back pain staring the following day also had fever 101 relieved by ALEVE. Resolved after 2 days.
The patient, received two doses of the primary series of the Pfizer COVID-19 vaccines at pharmacy. The first dose of the series was given on 9/24/2021 by CPhT, under the supervision of RPh. The vaccine was administered in the left arm, had a lot number of FE3592, and expiration of 11/30/2021. The second dose of the series was given on 10/15/2021 by CPhT, under the supervision of RPh. The vaccine was administered in the left arm, had a lot number of 30145BA, and expiration of 08/31/2022.   On November 3rd, 2023, around 9:45 AM, the spouse of patient, contacted us via phone at pharmacy. She stated that her husband had received two COVID-19 vaccines from us in 2021 and developed a seizure disorder around 6 weeks after, which they believed to be an adverse effect of the vaccines. Patient saw Dr., a neurologist at medical facility, but now sees NP. She stated that NP was going to report the incident but told her to reach out to our pharmacy to report it as well. I told her that we would get in touch with NP for more details and may need to call her back for more information prior to reporting the incident. She was very pleasant and stated that she understood completely. She asked about reaching out to Pfizer about it; I told her she could, but if she wanted to get any kind of compensation from them, she would likely need a lawyer. She did not show much interest in this idea; it seemed that she simply wanted to make everyone aware of the issue. I told her thank you for reaching out to let us know and was extremely sympathetic when she talked about how hard it had been since he had his first seizure. She thanked me again for my kindness and willingness to report the incident, and that was the extent of our conversation. I filed an incident report per our company's protocol on this same day.    On Monday, November 6th, 2023, at 10:39 AM, I reached out to NP, for more information about this incident. She stated that spouse and patient felt strongly that the COVID-19 vaccines he received from us were the cause of his seizure disorder, but she told them that there was not enough data to say one way or another. NP said that on 11/30/2021, the patient had a loss of consciousness and showed seizure-like activity at home. He was transported to hospital via ambulance and was started on levetiracetam 1,000 mg twice daily. This was his first and last known seizure; he has been treated prophylactically ever since. He followed up with Dr., a neurologist at medical facility, on 12/15/2021.  In March of 2022, he started seeing NP and stayed on the levetiracetam until June 29, 2022, when they started to titrate his dose down to start him on lamotrigine. He is still taking lamotrigine for this indication. NP did state that the patient had a motor vehicle accident in July of 2021, during which he had a ?close-hit injury? and flipped his jeep. She said he followed up with his primary care provider, following the wreck and the only note she saw was that he had a broken finger.  NP also added that this patient works at agency.
Hot flashes; A little bit of uncomfortable feeling; Night sweats; Black and blue where the shot was; Swollen at injection site; next morning it was bruised; When the needle was taken out it started to bleed/Left arm bleeding at injection; This is a spontaneous report from a contactable consumer (patient). A 85-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9264, NDC number; Expiry Date: unknown), via intramuscularly, administered in left arm on 28Jan2021 17:15 as single dose for covid-19 immunisation (prevention). The patient medical history was not reported. Other relevant medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness, genetic /chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity was none. There was no family history. There were no concomitant medications. There were no additional vaccines administered on same date of the Pfizer suspect. No previous history immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). No prior vaccinations (within 4 weeks). Flu shot a couple of months ago. No AE following prior vaccinations. The patient experienced when the needle was taken out it started to bleed/left arm bleeding at injection on 28Jan2021 17:30, night sweats on 02Feb2021, hot flashes, a little bit of uncomfortable feeling on an unspecified date, black and blue where the shot was, swollen at injection site was on 29Jan2021 10:00. She got first shot on 28Jan2021, and she is not on blood thinners. After the nurse took the needle out, it started to bleed. She said maybe she hit a vein. There was a little bit of uncomfortable feeling where vaccine was. The next day, she was black and blue where the shot was (The next morning it was bruised ("black and blue"). She got it around 5:15 pm. There was no prescriber. She did not speak with anyone in safety department, but she did speak with someone and she was going to change her over to someone else, but she never got to speak with anyone. She had a night sweats (It was after midnight at unknown time) and never had hot flashes ever. She felt very warm, and it went away. She took her temperature, and she did not have a temperature. If she gets second shot, she would like to know if she should get it in the right arm or left arm. Her next shot is due on 18Feb2021. There was no relevant test. No ER or physician's office required. There was no investigation assessment. There was no PQC (product quality complaint). The outcome of event hot flashes, a little bit of uncomfortable feeling was unknown and for other events it was recovering.  Follow-up attempts are completed. No further information is expected.
Hospitalization for shortness of breath due to COVID-19 on dates 8/4/2022- 8/9/2022.  Treated with baricitinib, vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
When I received the first dose 4/7/21, I had a burning sensation go up my left arm to my face.  My face felt hot and then my chest.  I felt scared like I could be having something wrong but I continued on.  I then got very tired.  The next day I felt achy knees. Two days later I started having buzzing in my ears but didn't realize it could be a side effect.  I went to a Urgent Care and was treated for a possible ear infection and given antibiotics.  That did not help or cure my condition.  The buzzing/ringing is on the same side/left as my injection.  On 5/5/21, I went for my second injection and asked if the buzzing/ringing or being on antibiotics was a problem, they said no.  The buzzing/ringing increased.  I went to my regular Primary Care doctor who didn't see anything  wrong.  She referred me to an ENT.  The ENT ran a hearing test.  The hearing test seemed to come back ok but I still have the Tinnitus.  The Tinnitus is worse at night and in the morning when everything is very quiet.  Some days are worse than others and I have seen no improvement.  I also am experiencing hot flashes.  They also happened after the first shot and increased after the second.  The Tinnitus is very bad at time and I want it to go away.  It is like buzzing in my left ear that is always there but sometimes I can tune it out.  I think it is important to report this as I have not had anyone tell me it is a possible side effect.  If it is than this needs to really be investigated and studied and communicated with people.  It is very disturbing as I have never had Tinnitus before.  I hope and pray it goes away and there are no other side effects.
2 days after administration, Patient developed redness in her arm which had spread from the injection site on her upper arm, down toward her forearm.  She was started on antibiotics on 11/4 for this issue in case it was infectious in nature.
Caller reported an AE for GARDASIL and GARDASIL 9. The caller said they had a patient who received their first dose of GARDASIL on 5/17/2011. The patient received GARDASIL 9 on 7/25/2023 which was the patient's second dose of an HPV vaccine. Confirm; first dose of GARDASIL on 5/17/2011. The patient received GARDASIL 9 on 7/25/2023 which was the patient's second dose of an HPV vaccine; No other AE.; This spontaneous report was received from a pharmacist and refers to a 25-year-old female patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 17-FEB-2011, the patient started therapy with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). On 25-JUL-2023, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (Inappropriate schedule of vaccine administered and interchange of vaccine products). No addtional adverse event was reported.
pt says the vax was not given in the top of the left arm but down lower in the arm.  She developed a hot, swollen, and hard spot at the injection site.  On the second day she has a white circle around the red circle around the injection site that resembles a bull eye.  Pt has not had any medication for her symptoms at this time.
Information has been received from an office manager referring an approximately 15 month old female patient without pertinent medical history or drug allergies. On 18-SEP-2018 the patient was in the office for her "well exam". At the same date she was administered vaccinated with VARIVAX(Subcutaneous,1 dose, lot # R002508, expiration date 25-JAN-2020) that was reconstituted with sterile diluent for prophylaxis. Other suspect therapies included DTAP and Meningococcal Protein Conjugate (manufacturer unknown). On an unknown date (reported as " couple days later") the patient experienced a "fever, diarrhea with vomiting and fussiness". The patient returned to the office with her mother on 01-OCT-2018. 2018 with a "macular rash on her abdomen and inguinal area" the patient was seen at the physician's office on 08-OCT-2018 with white creamy stools, vomiting, fussiness and crying constantly for the last few days. The patient had been diagnosed with gastroenteritis and exanthem. Unspecified treatment provided at Physician's office. The patient's mother was instructed to "keep patient hydrated, avoid heat and observe. The outcome of exanthem was recovered on an unspecified date of 2018. The outcome of other events was unknown. The causality assessment between the suspect medications and events was not reported.
Client alleges she started with a rash and eryhtema in arms, legs, chest, and neck over 24hrs after vaccine administration.
Fatigue, pale, jaundice, and little blood in diapers. 60 day follow up states pt is now receiving, on a monthly basis, ab IVIG treatment to boost his immune system due to the low dose chemotherapy (Rituxan) that was used to bring down his immune system to attack the antibody that was destroying  his red blood cells. His hemoglobin is now normal.
listed expiration date 9/30/22, stability data listed as good until 10/19/22.