chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2009, the patient was inoculated with ZOSTAVAX as recommended for routine adult health maintenance for the long-term prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster or shingles. In 2014, the patient was treated for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Injection site red that evening of vaccination. On 04/19/2002 the pt developed 6 inches of induration and was seen in ER, along with swelling. Diagnosed cellulitis. Treated with Keflex, warm compresses. The symptoms improved two days after on Keflex.
Kinrix and MMR-V were given in the Left deltoid and SubQ arm. Redness, warm to touch and swelling and pain at injection sites reported by Mother and PCP, states that "he cannot move his left arm" and that he had vomiting and diarrhea and fever at the time of immunizations. Mom told me that he had a little runny nose but no fever. Dr. gave a SoluMedrol injection for the inflammation.
No adverse effect; The patient received a dose of M-M-R ii via the intramuscular route in error; This spontaneous report was received from a pharmacist regarding a patient of unknown gender and age. Information on pertinent medical history and concomitant medication was not reported. On 03-MAY-2019, the patient received a dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) via intramuscular route in error for prophylaxis (dose, frequency and lot number was not reported) (Incorrect route of product administration). No adverse effect was reported. No product quality complaint was reported.
On the second day of receiving the vaccine the left arm  started with red spots on arm and on my hands, with a little swollenness in  left hand.
This spontaneous report as received from a pharmacist via a field employee refers to a female patient of unknown age. Medical history was not reported. On an unknown date the patient was vaccinated with PNEUMOVAX 23, (route, lot number and expiration date were not provided). Start date of therapy was unknown. Concomitant therapies included INFLUENZA. Vaccines were applied at separate injection sites on separate arms. On an unknown date the patient developed a "bump" at the injection site of PNEUMOVAX 23. The outcome was unknown. It is not known whether or not the patient had ever received PNEUMOVAX 23 in the past or if the patient notified her healthcare provider. Additional information has been requested.
1 week out symptoms started - hard lump, red, swollen, hot to touch, spread to about a 2 inch diameter
Between 8:00 PM and 8:00 AM experienced the following: severe nausea and vomiting, chills and shivering, room spinning, severe headache, weakness, couldn't stand, walk or sleep, extreme arm pain.
Pt recvd 3 doses of Engerix-B on 8NOV90, 14DEC90 & 2MAY91 Hep B surface antibody was neg; pt began the series again, recvd booster doses of Engerix-B on 22OCT91 & 25NOV91;
Patient had episode of low blood pressure, severe headache, taken to ER in AUG2021; Patient had episode of low blood pressure, severe headache, taken to ER in AUG2021; This spontaneous case was reported by a physician and describes the occurrence of HYPOTENSION (Patient had episode of low blood pressure, severe headache, taken to ER in AUG2021) and HEADACHE (Patient had episode of low blood pressure, severe headache, taken to ER in AUG2021) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LISINOPRIL for an unknown indication.   On 25-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, the patient experienced HYPOTENSION (Patient had episode of low blood pressure, severe headache, taken to ER in AUG2021) and HEADACHE (Patient had episode of low blood pressure, severe headache, taken to ER in AUG2021). The patient was treated with SALINE [SODIUM CHLORIDE] (intravenous) at an unspecified dose and frequency. At the time of the report, HYPOTENSION (Patient had episode of low blood pressure, severe headache, taken to ER in AUG2021) and HEADACHE (Patient had episode of low blood pressure, severe headache, taken to ER in AUG2021) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, Blood pressure measurement: low (Low) low blood pressure.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No medical history was provided by the reporter. Patient was taken to Emergency Room in August 2021.   Reporter did not allow further contact
warmness at the injection site; redness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (warmness at the injection site) and INJECTION SITE ERYTHEMA (redness at the injection site) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced INJECTION SITE WARMTH (warmness at the injection site) and INJECTION SITE ERYTHEMA (redness at the injection site). At the time of the report, INJECTION SITE WARMTH (warmness at the injection site) and INJECTION SITE ERYTHEMA (redness at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Treatment information was not provided.
4 days following vax pt developed discreet erythematous, raised papules around inj site on lt thigh & extending up lt flank; also had fever to 100.8; rash dec & localized by 7 days p/vax; no pruitic, no vesicles
Started with feeling tired around 6pm, woke up at 3:30 am (ish) to wanting to vomit, shivering, high fever over 103, aweful headache, dizzy, breathing feels labored.  Now at 12:30 pm, arm is extremely sore at site, chest still feels funny when taking deep breaths, head still aches but not as bad, not quite as tired.
Extreme dry mouth & tongue swelling approx 20 min after injection Chills approx 1 hour after injection Rapid heart beat for about 2 hours - occurring approx 1 hour after injection Itching at a hard lump at injection - still itching 3 days later Hip joint pain - I have extremely bad bone density in hips - pain on left hip after 24 hours and still hurting after 3 days
This case meets criteria for vaccine breakthrough review.  SxS - asymptomatic for COVID, incidentally found COVID+ with admission screen for separate issue.
I am having mild headaches - out of 10 it's 2. It's continuous headache- past 8 days I'm using  - three dosage of Ibuprofen  each day- 600 mg. It's in the front of my forehead in the center of my head.  Doctor  visit.
Initial information received on 23-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves three patients (less than 65 years-old) who received 0.5 mL vaccine FLUZONE HIGH DOSE instead of FLUZONE QUADRIVALENT (lot number, expiry date, route and site of administration were not reported for both) on 11-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was actual medication error due to inappropriate age at vaccine administration, overdose and wrong vaccine administered. It was reported that FLUZONE HD were not differentiated form the FLUZONE QUADRIVALENT and may have been given to patients under the age of 65 years. No adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Cellulitis at the site of MENACTRA vaccine went to hospital Emergency Room, placed on KEFLEX by Emergency Room personnel.
Caller said the crotch area is still very bad and itches like crazy; broke out in rash all over body/tried a lot of creams that eased it a little bit but other than that it's only cleared up stomach and back.; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (Caller said the crotch area is still very bad and itches like crazy) and RASH (broke out in rash all over body/tried a lot of creams that eased it a little bit but other than that it's only cleared up stomach and back.) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Type 2 diabetes mellitus and Pulmonary stenosis (stenosis in lung). Concomitant products included PARACETAMOL (TYLENOL), COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), CLOBETASOL PROPIONATE (CLOBETASOL 0.05%), DICLOFENAC, DIPHENHYDRAMINE, EMPAGLIFLOZIN, HYDROCORTISONE, LIDOCAINE, METFORMIN, METHOCARBAMOL (ROBAXIN), SIMVASTATIN and TRIAMCINOLONE for an unknown indication.    On 07-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PRURITUS (Caller said the crotch area is still very bad and itches like crazy) and RASH (broke out in rash all over body/tried a lot of creams that eased it a little bit but other than that it's only cleared up stomach and back.). At the time of the report, PRURITUS (Caller said the crotch area is still very bad and itches like crazy) and RASH (broke out in rash all over body/tried a lot of creams that eased it a little bit but other than that it's only cleared up stomach and back.) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications also includes Camphor menthol topical and Colloidal oatmeal topical.
Vaccine exposure during breastfeeding; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (Vaccine exposure during breastfeeding) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPOSURE VIA BREAST MILK (Vaccine exposure during breastfeeding). At the time of the report, EXPOSURE VIA BREAST MILK (Vaccine exposure during breastfeeding) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication information was provided.; Sender's Comments: This is a case of product exposure during breastfeeding with no associated AEs. Patient will continue to be contacted for further monitoring of AEs.
Experienced N/V/D after anthrax vaccines 1-3 (onset within 24 hours of vaccine receipt resolution within 24-48 hours of onset). No N/V after AVA #4-6. Increased diarrhea approximately 3 months following AVA# 3 and persisted for 6 months. Diagnosed with IBS in 07/2004. See clinical summary: Chief Complaint: " I got diarrhea after my anthrax vaccines." 33 year old ADA WM who was referred to the Vaccine Healthcare Center by Deployment Health. Patient is currently TDY while undergoing medical evaluations of new complaints following IED explosion while in Iraq. History of Present Illness: Patient has received 5 anthrax vaccines (07/31/03, 08/12/03, 08/28/03, 03/13/2004 and 10/04/2004). He denies any significance or unusual local reactions at vaccination sites. Within 24 hours of receiving each anthrax vaccine, he noted the onset of general body aches, decreased appetite, and watery diarrhea(at least 3 loose stools /day) These symptoms lasted approximately 48 hours before resolving without treatment.  After first 3 anthrax vaccines, patient recalls;;s experiencing nausea and vomiting 2-3 times emesis that considered of undigested food. 'In December 2003 (approximately 3 months after his 3rd anthrax vaccine), patient began experiencing daily diarrhea-8-9 watery, dark stools/day. Because of the intensity of the duties while deployed and limited access to health care, patient did not seek medical evaluation until 03/19/2004, which was 6 days after receipt of AVA#4. (pt does not recall diarrhea worsening until after vaccine receipt)He was seen at the bas, and his stool tested negative for blood, but was told he needed to be shipped stateside for further evaluation(while waiting for his orders, pt was involved in IED explosions 04/2004) Pt had discontinued his Glucophage in 01/2004 (on his own) the diarrhea was a related side effect. After going 4 months without Glucophage he did not notice a change in the diarrhea,He had been four months without Glucophage  and still did not notice a change in his diarrhea. He had been tired on Questran, but says diarrhea was worse while taking it. His diarrhea continued until around July/august 2004, when the number of stools and frequency declined to 3-4 stools/day, 7 days a week. Around 10/2004 after starting narcotics his diarrhea resolved(he does not recall experiencing  nausea, vomiting, or an increase in diarrhea following anthrax vaccine #5 given in 10/2004) He currently reports having 1-2 bowel movements per day which are described as normal (brown, formed, no blood or mucous) about 2-3 times /week. Patients medical evaluation has included an EGD and a Colonoscopy, both reported to be normal and evaluation by a GI specialist. He does not recall submitting stool analysis. Patient reports a sensation of urgency noted, but denies any associated vomiting ( except brief nausea and vomiting following anthrax vaccines 1-3) abdominal pain, or cramping, weight loss, or blood in his stools. He had a few episodes of stringy mucus mixed with his stool.  He denies having a history of bowel disease or food intolerance with associated diarrhea. He denies any symptoms of infection prior to receiving his anthrax vaccines.
Dizziness mostly head swimming; This is a spontaneous report from a contactable consumer (patient). A 70-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration, administered in the right arm on 19Feb2021 at 15:45 (at the age of 70-year-old) as dose 1, single for COVID-19 immunization at Hospital. Medical history included stoke 10 years before (unspecified date) and COVID-19, Prior to the vaccination, the patient was diagnosed with COVID-19. No allergies to medications, food, or other products. Concomitant medications were not reported, patient received other medications within 2 weeks of vaccination (unspecified). The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in Feb2021, at 15:00, the patient experienced dizziness mostly head swimming. The outcome of the event was not recovered at the time of report.  No follow-up attempts are needed. No further information is expected.
Extreme bleeding with first and second period after receiving second shot. Heavy cramping, extreme fatigue that affected normal daily activities. My menstrual cycle has been abnormal since receiving second vaccine.
soreness in the left arm / confined to injection site; swelling / in the left arm / confined to injection site / raised, softball-sized, around the site after the dose; hives / in the left arm / confined to injection site; redness / in the left arm / confined to injection site / red / around the site after the dose; nausea; malaise; vertigo; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a adult male patient who received Herpes zoster (Shingrix) (batch number X2Y32, expiry date 9th October 2022) for prophylaxis.   The patient's past medical history included shingles.   On 12th December 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 3 months after receiving Shingrix, the patient experienced injection site pain, injection site swelling, injection site hives, injection site erythema, nausea, malaise and vertigo. On an unknown date, the outcome of the injection site pain, injection site swelling, injection site hives, injection site erythema, nausea, malaise and vertigo were unknown.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site hives, injection site erythema, nausea, malaise and vertigo to be related to Shingrix.  Additional details were reported as follows: The patient experienced redness, swelling, hives and soreness in the left arm and were confined to injection site. The pharmacist looked at his chart it says it was red and raised, softball-sized, around the site after the Shingrix dose. The patient also had nausea, malaise, and vertigo. The reporter consented to follow-up. No other information was reported.
Information has been received from a licensed practical nurse concerning a patient who in 1982 and 1990 was vaccinated with a first and second doses of MMR II (Lot # and route not reported). In 2008 the patient was vaccinated with a third dose of MMR II (Lot # and route not reported). The nurse reported that the patient's titer was found to be "equivocal" after receiving several doses of the vaccine. The nurse reported that the titer was drawn in 2008 and 2010 but they were still "equivocal". No adverse effects were reported. It was unknown if the patient sought medical attention. Additional information has been requested.
At first it felt like I had a bad cold. It was unusually for my nose to be running. I thought I was allergic to something. Then, I got a really sore throat and a fever. The fever was constant every day until I got the monoclonal antibody infusion. I did not have extreme tiredness. It was more upper respiratory. My throat was really sore. I took extra strength Tylenol for the fever and Sudafed for the sore throat. When I tested positive in a medical setting, I got the antibody infusion. It took about 20 minutes for the infusion and then they checked me for an hour afterwards. I had a little bit of a reaction maybe to the infusion. I felt nauseous and sort of like I might pass out. I was also fairly hot like I was having a hot flash. I laid down on the bathroom floor and it passed. The next day I felt better. I had a very slight temperature of 99.2 and Tylenol helped it go away.  I isolated for more than 10 days. I feel normal today.
Developed generalized weakness, tingling in lower extremities and finger tips, bodyaches the evening of the day she received Tdap.
Large lump at site of injection with itching. Low body temperature 95.2-96.8 ongoing since vaccination. Body aches, chills, headache, skin pain.
Client went by ambulance to ER complaining that she became lightheaded the day after vaccination.  She Felt like she was going to pass out, but had no sensation of spinning.  Symptoms began after going to the bathroom and using the bathroom.  She laid on the floor and had what the ER practitioner described as a carpal pedal spasm of both hands and wrists, along with tingling of fingers.  EKG was done and WNL.  Client received lactated Ringers and symptoms improved and was sent home.
lost taste; lost smell; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (lost taste) and ANOSMIA (lost smell) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced AGEUSIA (lost taste) and ANOSMIA (lost smell). On 19-Mar-2021, AGEUSIA (lost taste) and ANOSMIA (lost smell) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment included acetaminophen.   This case was linked to MOD-2021-080846 (Patient Link).
Got shingles shots, got it (shingles) on thighs/Suspected vaccination failure; Got it (shingles) on thighs; Thought had pulled muscle; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Family History) (sister in law got it on her stomach and back andwasn't able to move.) and shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pulled muscle. The patient was treated with non-drug therapy (Heat Therapy). On an unknown date, the outcome of the vaccination failure, shingles and pulled muscle were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pulled muscle to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 19-SEP-2022 Reporter's Comment: This case was reported by a consumer via  interactive digital media. The reporter reported that it was an awful place to had shingles. The reporter's sister in law did not received Shingles vaccine and experienced shingles on stomach and back was not able to move. The reporter's girlfriend's mom got shingles on her face. The reporter husband got shingles on his thighs and he thought he had pulled muscle from doing yard work and put deep heat.  Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available. In the narrative it was stated that So glad you recovered' but its not clear if the patient was recovered or not hence outcome was kept unknown.  This is 1 of 3 cases reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR134884:Same reporter/ master case US-GSK-US2022AMR134931:Same reporter/ invalid case