chrisvoncsefalvay/vaers-outcomes huggingface dataset:
multiple outbreaks of herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.  On an unknown date, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, route of administration and anatomical location were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).  On an unknown date, after receiving zoster vaccine live (ZOSTAVAX), the patient suffered multiple outbreaks of herpes zoster. As a result of these symptoms, patient was seen and treated by medical providers and was still under their care.  As a direct and proximate result of zoster vaccine live (ZOSTAVAX), patient's symptoms have resulted in physical limitations not present prior to using the vaccine. Patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of patient's condition. As a result of zoster vaccine live (ZOSTAVAX), patient sustained severe and permanent personal injuries. Further, as a tragic consequence of Company's wrongful conduct, patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of Company's conduct, patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.
"Screaming" headache (started @ 8pm, increased til midnight, continued til 10am next day), extreme fatigue, body aches, diarrhea (2 days). Took Tylenol which lessened headache and body aches somewhat.
No adverse event; Bivalent doses administered after the BUD to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients) and NO ADVERSE EVENT (No adverse event) in a 51-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 11-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients).    Concomitant medications were not reported.  Total 51 doses from Lot AS7140C Bivalent doses were administered after the BUD to patients. Treatment medications were not reported.
Bleeding at injection and starting to bruise. Quarter size bruising at injection site (purple and yellow) within 4 to 6 hours of injection; joint pain, muscle aching, fever, lethargy within first 24 hours.  Still present but less severe 3 days post injection.  Patient's main complaint 3 days post in bruising at injection site and fatigue.
arm soreness, unable to lift left arm but able to move forearm, hand and fingers. pt has good circulation and sensation to left extremity.pt has taken ibuprofen, acetaminophen and applied ice pack on and off with minimal response.
Information has been received from a health worker (medical assistant) concerning unspecified patients of unknown age. Since 31-FEB-2014, improperly stored ROTATEQ (strength and dose were not reported) were administered to unspecified patients. No adverse effects were reported. Additional information has been requested.
Approximately 1 hour after receiving vaccines, patient re-presented to clinic with hives on face and back, but no vomiting or difficulty breathing, vitals stable.  Was given 20 mg IM diphenhydramine (pt unable to take oral), hives resolved and then pt was discharged home, prescribed oral diphenhydramine PRN.  Follow up today, pt did not have any recurrent hives but had developed low grade fever (100.4F in clinic) and L arm had significant local reaction with redness, swelling, mild warmth and pain to palpation but normal ROM and neurovascularly intact. Flu vaccine site (higher up on arm) looked ok, so reaction presumed from MMR.
I received 2 doses of the Pfizer Vaccine initially in Jan/Feb 2021, then did the heterologous boost with Moderna in December 2021.  I started having chills, fever, muscle aches around 12-14 hrs post shot. At 16 hours post shot I developed a 106.6 (hyperpyrexia) degree fever. The fever was managed with ibuprofen at home and brought down to about 101-102 that lasted until about 30 hours post. Felt very ill, nauseous, muscle aches, sore arm. tiredness for about 24 hours. I had very swollen lymph nodes (lymphadenopathy) for 6 days post shot, and generally feelings of tiredness. My menstrual cycle was missed. I have not have a period for 37 days now (as of 1/7/21), typical menstrual cycle length is 27 days.
PROFUSE SWEATING; CYCLES OF SHAKING; SEVERE HIP AND JOINT PAIN; CYCLES OF CHILLS; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and it has been requested. No concomitant medications were reported.  On 10-APR-2021, the subject experienced profuse sweating. On 10-APR-2021, the subject experienced cycles of shaking. On 10-APR-2021, the subject experienced severe hip and joint pain. On 10-APR-2021, the subject experienced cycles of chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from profuse sweating on 12-APR-2021, and cycles of shaking, and cycles of chills on 11-APR-2021, and had not recovered from severe hip and joint pain. This report was non-serious.
That night of the vaccine I started to have difficulty lifting my arm, then around 12:30am I was taking a shower and started feeling body ached and chills. Around 8 hours later I woke up with night sweats, and fever or 99.0 Fever started getting higher through out the day. The day after my temp was at 101. On the third day temp went away and I just felt fatigue, but I got chest tightness and the urge to clear my throat and some mucus came up. The chest tightness was two day and the mucus three days.
General Achiness; Headaches; Rapid heart beat after the first 15 minutes of the shot; General not feelin well or not right kind of feeling; Arm was sore; Stuff nose; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Rapid heart beat after the first 15 minutes of the shot), VACCINATION COMPLICATION (General not feelin well or not right kind of feeling), PAIN IN EXTREMITY (Arm was sore), NASAL CONGESTION (Stuff nose) and PAIN (General Achiness) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced PALPITATIONS (Rapid heart beat after the first 15 minutes of the shot), VACCINATION COMPLICATION (General not feelin well or not right kind of feeling), PAIN IN EXTREMITY (Arm was sore) and NASAL CONGESTION (Stuff nose). On 23-Jan-2021, the patient experienced PAIN (General Achiness) and HEADACHE (Headaches). The patient was treated with PARACETAMOL (TYLENOL) for Ache, at an unspecified dose and frequency. On 21-Jan-2021, PALPITATIONS (Rapid heart beat after the first 15 minutes of the shot) and VACCINATION COMPLICATION (General not feelin well or not right kind of feeling) had resolved. On 25-Jan-2021, PAIN (General Achiness) and HEADACHE (Headaches) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm was sore) and NASAL CONGESTION (Stuff nose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Titinus occurred about 10 days after the first doze. I was watching TV. Suddenly my ears ring so loud. I thought it would go away if I rest. But no. Once it started, it is 24 hours a day, non-stop. Now it has been 3 months. The ring volume is not as loud as the first occurrance. But it will sometime get louder and calm down a little. My right ear has more issue than left ear. Right ear feels a little clogged and ring. Sometimes I feel the ring only come from right ear. occasionally I can hear it from left ear.  I tried to massage the muscle around my right ear. It helped. But the ring is still there. I try to make my surrounding sound loud to cover the ring. It will help. But if the surrounding sound are off, the ring becomes very loud. If I put on headset or ear plug, the ring is very loud and clear.
It was reported that a male patient received a TD vaccination on 10/27/99. Approximately 16 hours post vaccination the pt developed a transient fever. Correspondence received 12/1/99, provided complete patient and phsyician data and stated that the patient has recovered from the reaction. This case is closed.
At 10 minutes, throat became scratchy and  uncomfortable, became lightheaded. Throat discomfort eased at about 10 minutes later. Lightheadedness lasted about 15 more minutes. Was not as severe as anaphylacsis.
High fever, chills, uncontrollable shaking, nausea, headache, extreme back ache, weakness, lightheadedness, faintness of breath, pain in the left arm, loss of appetite: these lasted for 24 hours, then gradually faded. It was one of the most severe flu-like episodes I have ever experienced. Now, 6 days later, I am experiencing lightheadedness, weakness, extreme anxiety, fatigue, and loss of appetite.
-Red, hot, swollen skin on left leg, pt feeling fatigued: called in for med eval on 8/30 and advised to use cold compress and ibuprofen and go to the ER if symptoms get worse. -Patient seen for evaluation on 8/31 and prescribed hydrocortisone cream. -Per 9/5 phone call patient was seen at the ER and prescribed antibiotics for cellulitis on both legs.
Face & neck started swelling at 11:00 P.M. on 10/23/2008.  No improvement by 10/26/2008.  Physician evaluated her and said she had parotitis with retained fluid.  Instructed her to take BENADRYL + IBUPROFEN.  Some improvement by 10/27/2008.  Nurse pract.  ordered CBC (WNC).  Continued improvement 10/28/08.
This case was reported by a pharmacist via call center representative and described the occurrence of headache in a 76-year-old male patient who received SHINGRIX for prophylaxis. On 31st May 2018, the patient received the 1st dose of SHINGRIX. In June 2018, 7 days after receiving SHINGRIX, the patient experienced headache. On an unknown date, the outcome of the headache was not recovered/not resolved. The reporter considered the headache to be related to SHINGRIX. Additional details were provided as follows: The patient noted he did not have this issue before SHINGRIX. The patient started with a headache about a week after the vaccine and had continued to have it. The patient was referred to his physician.
I gave the Pfizer COVID-19 vaccine to the patient around 10:20 AM and about 5 minutes later the patient began to "not feel well" while sitting in the waiting room. We got the patient water and a wet paper towel. Patient became nauseous so we got her a trash can that she threw up in. Department 50 was paged. Patient expressed needing to stay close to the floor as she has passed out from vaccine before so I got a mat we had and laid it out in the counseling room and assisted patient to floor. Department 50 showed up and talked with patient: EMS service was offered and denied. Department 50 called off when she said she did not need anyone called and was feeling much better. About 20 minutes later, patient felt well enough to walk around, and I walked with the patient out of the store to ensure she was feeling better.
rash at injection site; ard bump at injection site; pain in their left shoulder; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (pain in their left shoulder), VACCINATION SITE RASH (rash at injection site) and VACCINATION SITE INDURATION (ard bump at injection site) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced ARTHRALGIA (pain in their left shoulder). On 18-Feb-2021, the patient experienced VACCINATION SITE RASH (rash at injection site) and VACCINATION SITE INDURATION (ard bump at injection site). At the time of the report, ARTHRALGIA (pain in their left shoulder), VACCINATION SITE RASH (rash at injection site) and VACCINATION SITE INDURATION (ard bump at injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Severe joint pain, severe chills, feverish, headache, severe fatigue; all resolved within 48 hours. Tenderness, swelling and redness at local injection site, all still present. Redness about 4" diameter. Required me to take a sick day for work
Mild chills and joint pain started in the middle of the night (about 12 hours after second dose). Treated with ibuprofen and resolved about 10 hours after onset. Swelling and lump the size of a quarter at injection site noticed about 10 hours after injection. The next morning size increased to about 4 inches in diameter, skin was hard, hot, and painful to touch. Left armpit is also swollen and mildly painful. Now, (3 days after injection) swelling still present. Still hot and hard to the touch and size remains the same. Pain and redness mostly resolved. Now starting to itch.
I have been tested for COVID and was positive; Headache; fever; head and chest congestion; head and chest congestion; sneezing; This is a spontaneous report from a contactable consumer (patient). A 46-year-old non-pregnant female patient received bnt162b2 (BNT162B2 reported as PFIZER COVID VACCINE; lot number: EN5318; expiration date: unknown) at 46-year-old vaccination age via an unspecified route of administration in the left arm on 24Feb2021 13:15 at a single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included vitamin D nos (VITAMIN D) and birth control medication. The patient reported that she received the vaccine in her workplace clinic. She reported that she had headache, fever, head and chest congestion, sneezing, and nausea. The events did not require treatment. The patient further mentioned that she had been tested for COVID and was positive on an unspecified date (also reported as has not been tested post vaccination, pending clarification). She believes that is why she had those symptoms, not because of the vaccine itself. She received the vaccine on 24Feb2021 with symptoms appearing the following day (25Feb2021). She and her friend were with the day prior to getting the vaccine has tested positive for COVID as well (also reported as covid prior vaccination, pending clarification). The outcome of the events was recovering.; Sender's Comments: The patient received bnt162b2 (BNT162B2 reported as PFIZER COVID VACCINE) on 24Feb2021 with symptoms appearing the following day on 25Feb2021.   She tested for COVID and was likely positive on an unspecified date. The reported events including suspected COVID-19 test positive were unrelated to the vaccine bnt162b2.
pt recv vax & devel a mild case of chickenpox w/8 lesions on face & 5 on body;there were no prodromal sx;
Patient fainted within 15 minutes of vaccination.  Patient felt better after resting and was released to home.
THERE HAD BEEN LITTLE DROP IN THE ANTIBODY LEVEL; This spontaneous report received from a patient via a company representative concerned a 60 year old male. The patient's height, and weight were not reported. The patient's past medical history included: contracted covid-19 infection, and other pre-existing medical conditions included: Patient was in good health. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported.  On an unspecified date, the patient experienced there had been little drop in the antibody level. Laboratory data (dates unspecified) included: Antibody test (NR: not provided) little drop in antibody level. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of there had been little drop in the antibody level was not reported. This report was non-serious. This report was associated with product quality complaint: 90000233238. This case, from the same reporter is linked to 20220560642.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case is assessed as non serious
Information has been received from FDA (VAERS #286767) concerning a 4-year-old female with a history of hand syndactyly who on 30-JUL-2007 was vaccinated with the first SC dose in the right arm of MMR. Concomitant vaccines administered on that same day included a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid and a dose of poliovirus vaccine inactivated (unspecified). There was no other concomitant drug therapy or illness at the time of vaccination. On 30-JUL-2007, within 10 minutes of being vaccinated, the patient experienced an allergy to the vaccine, an anaphylactic reaction, dyspnea, flushing, hypersensitivity, rhinorrhea, sneezing, swelling face, tachycardia, throat tightness ("throat closing") and vomiting (mucous emesis). The patient was taken to the Emergency Department (ED) where she was treated with epinephrine, BENADRYL and SOLU-MEDROL. NO laboratory/diagnostic tests were performed. The patient as discharged to home from the ED and subsequently recovered. The patient's events were considered to be life-threatening. This is an amended report. (rHA) was added to MMR throughout the narrative. No further information is available.
The Tdap injections were stored in a refrigerator in which the temperature gauge malfunctioned and temperature reached 10 degrees; this incident occurred over a long holiday weekend (1/1/16-1/4/16) the exact date and time of the decrease is unknown.
After 14-15 days of the Vaccination, i have started seeing inflammation/Liquid build up/pain on both of my knees and stiffness behind left knee. Visited my primary care physician and he checked & suggested to use the knee cap after doing X-ray. As per discussion with Doctor, x-ray results are normal.  i used the knee cap for a week and swelling is reduced ,and again increased depends on how much i rest or walk. again following week i visited the primary care doctor and he observed the increased swelling on both knees and referred me to rheumatoid arthritis specialist. meanwhile i also insisted my Primary care doctor to do the blood work to check if i have arthritis. Blood work results came as normal.   I went to meet rheumatoid arthritis Doctor on June 14th and he looked into all the data checked my knees etc. He felt all are normal and again asked me to do the blood work to check if i have any other type of Arthritis. Today(06/21/2021) i got back the results from the doctors office saying all are normal. but i am not sure why this started happening to me .   The symptoms are  knee pain/inflammation, All joint(shoulders/ankel) pain - on and off.  mild head ache.  The only pointer i believe is Covid Vaccine is something to do with what i am going through now.  but i don't know for sure and how to resolve my inflammation issue. Any advise would be greatly appreciated.   I used to play Tennis before the vaccine frequently(3-4 days a week) and post this event i couldnt even walk actively as before as the inflammation increases based on the effort.
Just pain in my arm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Just pain in my arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced MYALGIA (Just pain in my arm). At the time of the report, MYALGIA (Just pain in my arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant Medications were not provided by the reporter. Treatment Medications were not provided by the reporter
Moderna COVID-19 Vaccine EUA Received 2nd shot/dose at approximately 0935 on 2/15/21. At approximately 0830 on 2/16/21 started with body-wide muscle aches that continued throughout the day and became quite severe. (did consider this normal side effect) Slept majority of the day. On 2/17/21, at approximately 0800, noticed body-wide hive-like rash (bright red, slightly raised, not itchy) on my torso, back, upper arms and upper legs; slowly faded throughout the day.
maculopapular rash behind ears, neck, thorax asymptomatic, afebrile t98.8R; no treatment;
Woke up next day hands covered in rash and initially thought it was hives but some of the spots turned into blisters. They were very itchy the first 3 days
H1N1 vaccination adverse reaction, side effect redness in eyes and lids approx 5hrs after injection. Took Benadryl 2 25mg Approx 2hrs after eyes returned to normal color.
About 12-14 hours after second dose of Moderna COVID vaccine (March 16, 10PM to midnight), I began to experience fever, then chills and felt severe flu-like symptoms.  I started feeling better around 2:30 AM on March 17.  I went to work that morning at 8:30 and had to leave work at 10 AM due to feeling worse.  I went home and laid down the rest of the day, taking Tylenol and drinking an electrolyte drink.  I had chills, but not nearly as bad the the night before.  I started feeling better around 6PM that evening.  The next day, I felt fine with the exception of an almost total loss of appetite.   I did not feel fully back to normal until Friday morning.  I do not regret getting the shot, but found this reporting tool and thought it would be a good idea to submit my experience.
Constipation, green sticky poop that is much drier then previous bowel movements, very gassy and irritable.  Lack of appetite.
Close exposure to COVID-19 virus  Upper respiratory infection, acute  Contact with and (suspected) exposure to covid-19