chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Client states around 9:30 that evening she had an outbreak of rash, itching starting on her hands & then all over body.  Stated had swollen lips & had a hard time breathing when lying down.  Used inhaler & Benadryl.  Had swollen chin this am.  Also states she ate shrimp last night.
Patient states; "I feel like its going through me.  All through my body up to my head."   Nurse took vitals:  Pulse 73, O2 95%, BP 168/96, Temp 98.0F, respiration 26. Monitored for 15 minutes, blood pressure was taken again it was 160/92. Patient recovered and left.
Rash on left arm. The rash has continued to spread throughout my body. Mostly on the left side of my body. I now have the rash on my entire left arm, parts of the right arm and back (mostly on the left hand side of my back)
Patient collapsed in the parking lot. She never lost consciousness. She said she was having trouble catching her breath and said she was having trouble seeing. The paramedics were called and transported her to a local ER.
Initial non-serious case received from a consumer on 15 October 2008.  A 63-year-old female patient with history of diabetes, asthma and allergies to adhesive and thimerosal received a 0.25ml dose of FLUZONE No Preservative 2008-2009 (lot number and route/site of administration not reported) on 13 October 2008 and within minutes, the site was red and itchy.  A bandaid was placed over the site.  When removing the bandaid, a two inch "welt" was noticed.  On the evening of 14 October 2008, a very itchy red blotch, approximately the size of a dime, was noticed on the patient's right calf.  Patient outcome was reported as 'not recovered'.  Documents held by sender:  None
30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date).    This case contains information for the 21st of 30 adult patients described by the reporter.  Concomitant Medication use information was not provided by reporter.  There was 13, 11, and 6 different doses given. The 30 patients received Monovalent Moderna Vaccine past the manufacturer's expiration date.   The batch lot number was reported as 022D21A which was expired on 20 April 2022. The Lot number 033F21A which was expired on 08 April 2022. The Lot number 037C21A expired on 02 January 2022.  Treatment Medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-703461.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-703461:Master case
On 9/8/2016 recd a Flu vaccination and Pneumonia booster (PPSV23) on same day. Mild headache afternoon of 9/8. The next day (9/9) woke w/headache, nausea, no appetite, no energy. Noticed vaccination spot on arm was now 2 red sore spots. (9/10) Felt somewhat better, but still a headache and feeling tired, no appetite and the vaccination spot on arm, still sore.  (9/11) Better but still a continuing headache and feeling tired. (9/12) Middle of night woke up to another headache.  Feeling better - hoping that feeling like this is over.  I've RARELY had headaches and now since this I do hope it's not something I have to deal with on a daily basis.
After the second vaccine, right side of body has severe muscular pain, neuropathy, tingling, burning, stabbing sensations. Nausea, diarrhea, headache. Right arm, hand, trunk, rib cage, hip, leg, foot pain and tingling. Mild fever and right side head, neck and throat tight. Right shoulder nerve and trigeminal nerve are inflamed and the pain in my arm is terrible as well. The pain comes and goes, however when the pain comes, it is excruciating.
fever (100.5 F), fatigue, body ache, head ache, nausea, vomiting.  Symptoms began in the evening of March 10 and were the most severe throughout the day on March 11.  Symptoms were gone by the morning of March 12.
A pharmacist reported that a 16 year old male received Antivenin Polyvalent, Equine following a snake bite on 10/26/00 and subsequently, developed a total body rash and became anxious. A second dose of Antivenin Polyvalent, Equine was administered following treatment with diphenhydramine and methlprednisolone; however, the infusion was discontinued because of rash progression. Additional information received 01/17/2001 indicated that the patient was hospitalized for 2 days.
MISSED THIRD DOSE; TOOK TWO DOSES WITH FOOD; A spontaneous case report was received from a consumer on 17-Jan-2019 for three consumers.  Based on the information obtained from the consumer, three individual case safety reports PVX201901-000046 (PVX2019-172; mother), PVX201901-000047 (PVX2019-173; son) and PVX201901-000048 (PVX2019-174; husband) were created and cross-linked in the database.  This case report describes an adult female consumer who "missed third dose" and "took two doses with food". The consumer was receiving Vivotif for an unknown indication.  It was reported that the consumer took the doses of Vivotif on 12-Jan-2019 and 14-Jan-2019 with a snack, milk and drink. She also missed her third dose which was due on 16-Jan-2019.  The action taken with Vivotif with respect to events "missed third dose" and "took two doses with food" was not applicable.  The clinical outcome of the events "missed third dose" and "took two doses with food" was unknown.  Company's Comment: The causality of the events "missed third dose" and "took two doses with food" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the events "missed third dose" and "took two doses with food" was considered as not applicable. US-PaxVax Berna GmbH-PVX201901-000047: US-PaxVax Berna GmbH-PVX201901-000048:
vaccine vial was diluted with 1.6 ml instead of 1.8ml so patient received larger dose than expected.
Patient states that she had swelling and whelp the size of a softball that lasted for 2 weeks.  The patient states she had pain at the site for the same amount of time.
Information has been received from a physician concerning a female who in approximately May 2008, was vaccinated with GARDASIL SC instead of IM.  On approximately 02-JUN-2008 the patient experienced discomfort.  The patient experienced a bump under the skin at the injection site on approximately 02-JUL-2008.  The patient's bump at the injection site and discomfort persisted.  The patient sought medical attention and called the physician's office.  Additional information has been requested.
6 days p/vax pt devel rash around inj site; initially had a few red bumps then spread rapidly until an 8.6cm area was affected & red bump colased; warm to touch & itchy; faded much by next morning;
After receiving the first vaccine on 12/29/20,  I woke the morning of 12/31/20 with muffled hearing in my left ear. This lasted for the entire day of 12/31. When I woke up the next morning 1/1/21, the muffled sensation in my ear was gone, but I noticed a ringing in my left ear only. The left sided tinnitus continues, 3 months later.
I had an electrical jolt run from the back of my neck into the scalp and down the left side of my neck into my left arm with pain pressure and soreness in these area and in the base of my head with some confusion and stiffness in the left side of my face followed by the right side. This lasted for six days afterward
After typical flu like reaction for 2- 3 days, symptoms of Epstein Barr- extreme exhaustion, muscle weakness and aching, swollen glands and headache started about day 5 and have been severe times one month.
Developed GBS. All of a sudden fell in April 2004 and could not walk. Hospitalized untill 11/28/04. Had spinal tap to confirm GBS. Had plasmaphoresis to clear blood - 18 treatments. Currently in therapy; wearing braces on legs. Per follow up report received on 06/23/2005:  Patient's reflexes remain absent, numbness in both feet, irregular areas on both lower legs.  Right foot/ankle still unable to flex joint at all.  Needs walker and wheelchair for ambulatory efforts.  Balance remains affected, not stable when standing up - fingers are numb.  Motor skills not possible to do.  Information received from Discharge summary sttes numbness, weakness, clumsy, constipation, confusion nd elevated hemi-diaphram as symptoms; from medical records, hypotension, pin, agitation, chest pain, tachycardia. msv  Per follow up report-Right ankle still paralyzed.  APO brace required to walk. Use cane so well for short simulations. Uses wheelchair to enable independent daily living tasks in house. Still have short tremors in hands and feet associated with pain. Extremities still painful to coldness, i.e. cold weather=increased pain often disrupting sleep. Is there monetary compensation from manufacturer? Patient can not work as a result of this adverse reaction.
This spontaneous report was received from a physician via company representatives, referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 24-SEP-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (Lot No. J007946; expiration date 24-MAR-2016), (route of administration and anatomical location of administration were not reported). On an unspecified dates, the RECOMBIVAX HB had one temperature excursion of 120 hours and the lowest recorded temperature was 34 F (1.111111111 Celsius). No adverse effects reported. The vaccine status was reported as "in excursion". The vaccine storage criteria and the storage type of excursion were reported as "Refrigerator(R)". No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
This spontaneous report was received from a consumer and refers to her currently 8-year-old step-son. The patient's concurrent condition included fish allergy and concomitant medication included CLARITIN. He had no drug reaction/allergies. The patient's medical history was not reported. On an unknown date in 2010 (reported as "sometime around 2010"), the patient was vaccinated with a dose of M-M-R II intramuscularly (exact dose, dose number, site of administration, lot # and expiration date were not reported) for routine vaccination. On an unknown date around 2010 or 2011, he developed autistic tendencies and issues with focus and attention. The treatment was not given for the events. No laboratory test was performed. The reporter also stated that the patient was incredibly intelligent and brilliant. The outcome of the events was reported as not recovered/not resolved. The relatedness between the events and M-M-R II was not provided. Upon internal review, the event of autistic tendencies was considered to be medically significant.
This spontaneous report as received from a physician and a healthcare worker refers to a patients of unknown age and gender. Information on concurrent condition and medical history was not reported. On an unknown dates, the patients were vaccinated with improperly (Merck) VARIVAX lot # L040419 (expiry 14-OCT-2017) and L040421 (expiry date 15-OCT-2017) (dose and route not reported). The temperature excursion time frame was reported as "-4.7 C for 682 hours, -5.3 C for 130.45 hours (-14.9 C to -10 C for 121.95 hours, -9.9 C to 5.3 C for 8.5 hours)". No previous excursion was reported. No adverse effects was reported. This case is one of the several reports from the same reporter. Additional information has been requested.
pt devel an inj site rxn w/ swelling which extended from shoulder to elbow & hives on posterior of arm;few wk later devel myoclonic sz;EEG showed focal & gen sz;1NOV96 dx of focal rt hemisphere sz disorder w/secondary generalization
Headache, Myalgia, Fever, chills, chest pain, sweats. Narrative:
Upset stomach; rash appearing on all over her body (Face, arms, chest and back).; body ache; fever (reached "101 to 99degrees"); This is a spontaneous report from a contactable consumer (parent) or other non hcp. A 25-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0170 and expiry date: unknown), dose 2 via an unspecified route of administration on 29Apr2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received dose 1 of bnt162b2 on an unknown date for covid-19 immunisation (lot number: EP7533/ Anatomical location: right arm). The patient experienced body ache and fever (reached "101 to 99degrees") on 14May2021, rash appearing on all over her body on 18May2021 (broke out on Tuesday/ states it is similar to a prickly heat or roseola type rash), upset stomach on an unknown date (the reporter states the patient was three weeks past vaccine today). The reporter states that she has read that it has been reported that 7-14 days after second dose, people are having similar symptoms, reporter wants to know if this has been reported. Outcome of the events rash appearing on all over her body (Face, arms, chest and back) and body ache was not recovered, fever (reached "101 to 99degrees") was recovering, Upset stomach was unknown.  Follow up (20May2021): This is a Follow-up spontaneous report received from a contactable consumer.  Information on Lot/Batch number was available. Additional information has been requested.
Information has been received from a nurse concerning a 12 month old female with a ear infection and with no pertinent medical history or drug reactions/allergies reported who on 9:50 am on 06-OCT-2003 was vaccinated with a dose of VARIVAX (Merck) (lot# 645163/0205N) 0.5ml SQ in 4-5 cm posterior aspect of her left thigh and a dose of MMR II (dose and administering site not reported). Concomitant therapy included antimicrobial (unspecified) for the ear infection. Within 5 days after the vaccination the patient developed a maculopapular rash over her upper extremities, most of lower extremities, trunk and face. No lab diagnostic were performed. The physician defined the rash as "eruptions likely from the vaccination with a urticarial component". Subsequently, the patient recovered. The patient sought medical attention in the office. Additional information has been requested.
Patient states after being given Influenza and Hepatitis A vaccine 12/01/14 around 1 pm she had no symptoms but later that night developed hives on her arm.
the patient's doctor has recommended another pneumonia shot, because the patient is immunocompromised due to the splenectomy.; This spontaneous report was received from a male patient of unknown age regarding himself. The patient had no drug reactions or allergies and none concomitant medications.   The patient stated that he ruptured his spleen in a softball game. Due to him rupturing his spleen in the softball game he needed to have a splenectomy performed on him "between 5 and 10 years ago". During the splenectomy the patient was admitted to a hospital for 8 days. Soon after the splenectomy the patient received 2 pneumonia shots of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), (dose, route, lot number and expiration date were not reported) in his arm (unsure which arm was). At the time of the call the patient's doctor has recommended another pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) shot, because the patient was immunocompromised due to the splenectomy (experienced product prescribing issue).
tested positive for Covid; tested positive for Covid; This is a spontaneous report, received by a contactable consumer (patient).  A male patient (age not provided) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number not provided), via an unspecified route of administration, on 17Mar2021 at single dose for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. Second dose was scheduled on 07Apr2021. After first shot, the patient had bad symptoms so he got a test for COVID-19 which resulted negative. He continued to have bad symptoms, so he had a test again on 30Mar2021 which resulted positive. The outcome of the events was unknown.  Information on the Lot/Batch number has been requested.
Site reaction: red, swollen, pain. Ice applied to area. Re-assess in 20 minutes showed improvement. Follow up phone call in evening: discomfort and advised TYLENOL. Next day follow up call with father report improved and no new concerns at the time.
I had swollen lymph nodes in my neck, jaw, and arm-all on the left side; This is a spontaneous report from a contactable consumer (patient herself).  A 47-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 28Apr2021 as DOSE 2, SINGLE (age at vaccination was 47-years-old) for covid-19 immunisation. Medical history included cervical radiculopathy, peri menopausal (menopausal symptoms) and gastrooesophageal reflux disease. Concomitant medication(s) included gabapentin 100mg and multivitamin. Known allergies: Amoxicillin and azithromycin. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: ER8729), via an unspecified route of administration, administered in Arm Right on 07Apr2021 08:30 as DOSE 1, SINGLE for covid-19 immunisation with adverse event of heavy menstrual bleeding. On 01May2021, 3 days following second vaccine, she had swollen lymph nodes in her neck, jaw, and arm-all on the left side. She got the shot on her right arm. She reported that the swelling comes and goes since then but persists. It was reported that the patient did not have Covid prior to vaccination and Covid was not tested post vaccination. At the time of this report, the outcome of the event was recovering.  Follow up activities completed. No further information is expected.
Arm is very sore; This is a spontaneous report from a contactable consumer. A 77-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9261), via an unspecified route of administration in left arm on 27Jan2021 10:00 at a single dose for COVID-19 immunisation. The patient's medical history was not reported. Prior to vaccination, the patient has not been diagnosed with COVID-19. Concomitant medications included metformin. The patient experienced arm is very sore on 27Jan2021. The event was reported as non-serious. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse event. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Patient began having chills, fevers and sweats within 12 hours of receiving the vaccine. 2 days later he had severe chest pain prompting him to present to the hospital.
Case number PHEH2015US002936, is an initial spontaneous report received from a nurse on 06 Feb 20155. This report refers to a 46 year old male patient. Medical history and concomitant medication was not reported. On 14 Jan 2015, he received FLUVIRIN (batch number: 146525) 0.5 ml intramuscular that reached 48 degree Fahrenheit for 9 hours. Event outcome, seriousness and causality assessment was not reported. No further information was provided.
Later in day of administration, pt experienced bad headache, muscle aches. Nausea. Arm hard to lift, achy 2 days later still has pain at injectionsite hurts to lift arm. Still has "massive" headache & nausea
Pt called pharmacy on 9-20-10 reporting a "hematoma" that looks greenish/purple/blue, about 3" across, and painless at injection site. He said it appeared about 2 days after receiving immunization, which was on 9/12/10, and is still very apparent 8 days later.
I received the 1st vaccine on March 4th. Only had a sore arm. Then on March 10th I woke up before 2:00 that morning itching all over. At 6:30 am I was covered in painful rash from behind my knees to my shoulders. It itches and hurts. I went to immediate care at which time they gave me a steroid shot, antihistamine tablets and a cream. Today it got so painful I went back to immediate care and was given a shot of epinephrine and given an epipen. The rash is raised and deep red. Very itchy and painful. It is now on my hands as well and they are stiff and swollen. Both doctors that I seen suggested going to regular physician before taking second dose of vaccine
4 year old female with localized erythema, swelling right leg on 3/26/05. Admitted 3/27/05 for cellulitis. Treated with antibiotics and recovery.
Approximately 14 days after the  1st does of the Covid vaccine was administered, I noticed a rash at the injection site (upper left arm).  This rash was red, slightly bumpy, and itchy.  Over the next 10 days the rash spread down my left arm across my chest, and down my right arm.  The rash was hot to the touch and was itchy.  I received by 2nd dose of the Covid vaccine on 2/24/21.  The itching became quite severe and it kept me awake at night.   Over the counter itch treatments did not help alleviate the rash or the itching.  On 3/3/2021, I finally went to an urgent care facility to get help to stop the itching.  I was given a steroid injection, a topical hydrocortisone prescription, and told to take Claritin/Zyrtec Daily.   I had temporary relief of the rash and itching for about a week to 10 days  but the rash and itch returned on my arms and chest and spread up my neck, on my ears, and across my back.  I returned to the urgent care facility on 3/18/21 .  They prescribed a 7 day oral steroid treatment and told me to continue to take the Zyrtec and treat with over the counter itch ointment.  I followed up these urgent care visits with a visit to my primary care physician on 3/26/21.  The rash was still present at this appointment but the rash and itch had started to improve.  Blood work taken at the appointment showed Eosinophils sl high (possible allergies).  The rash and the itch finally resolved by around 4/3/2021.