chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shingles in eye; arm pain at injection site; fever; chills; This case was reported by a consumer and described the occurrence of ophthalmic herpes zoster in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included ophthalmic herpes zoster (had shingles in eyes, especially the right eye, numerous times years ago). Previously administered products included Shingles vaccine with an associated reaction of no adverse event (received the original Shingles vaccines a few years ago and did not experience any side effects, did not get shingles again). Concomitant products included metoprolol succinate and lovastatin.   On 15th June 2022, the patient received the 1st dose of Shingrix. On 15th June 2022, less than a day after receiving Shingrix, the patient experienced injection site pain, fever and chills. On an unknown date, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant). On an unknown date, the outcome of the ophthalmic herpes zoster, injection site pain, fever and chills were recovered/resolved.   It was unknown if the reporter considered the ophthalmic herpes zoster, injection site pain, fever and chills to be related to Shingrix.     Linked case(s) involving the same patient:  US2023AMR009326   Additional Information: GSK Receipt Date: 20-JAN-2023 Reporter's Comments: The case was self reported by the patient. The patient received first dose of Shingrix at her physician's office and experienced arm pain at the injection site and fever and chills the night she received the vaccine. The patient also had shingles in right eye for several days but it cleared up on its own. The patient had now spent over one thousand dollars out of pocket for doctor visits, prescription, lab work, and treatments. The patient had been to an urgent care clinic run by her primary care physician practice, had been to the eye doctor at least 5 times, and her PCP once.  The patient now being treated by a cornea specialist who did a procedure on her eye and she had to go back to next week. All of the health care providers the patient had seen said that none of the literature on the vaccine lists this as a possible reaction. The symptoms was treated. The reporter did not consent to follow up. Additional Supportive Information: For tolerance of 2nd dose, refer case US2023AMR009326.; Sender's Comments:  US-GSK-US2023AMR009326:same reporter - 2nd dose
fever onset of rash 5 days ago, rash on tongue, no known exposure to varicella, recv varivax SEP98;dx varicella post varivax;
Information has been received from a consumer concerning a 12 month old male pt with no medical history who on approximately 05/11/03 was vaccinated SC with a 0.5mL dose of MMRII. Concomitant therapy on approximately 05/11/03 included a dose of varicella virus vaccine live. Ten days later, on approximately 05/21/03 the pt developed a rash (# of lesions not known) all over the body. Subsequently, the pt recovered on his own in one week. It was noted that the pt's twin sister had the same experience (WAES # 0308USA01722).  Additional information has been requested.
I noticed PMS symptoms a day after the vaccine (i.e. swollen breasts), which I found surprising because I was not due for my period for a few weeks. Then, I developed what I thought was an odd rash on the back of my leg. After a week, the rash had grown larger, and I started to get a rash on the other leg. I also got my period a week earlier than expected (which never happens). I contacted my doctor, and was told that I had petechiae (bleeding under the skin). I still need to get additional tests, but the petechiae is only getting worse.  Also, I will add that after my second dose of the vaccine, I developed very thick and numerous chin hair that I'd never had before. I didn't initially connect such an odd phenomenon to the vaccine, but since the vaccine has really messed with my hormones this time around (the third time), I wonder if it affected my hormones before as well (causing the facial hair growth).
Patient is 16 and received the 1st dose at a mass clinic. Mom reports that there has been no adverse effects
This spontaneous report as received from a nurse refers to a 4 years old patient of unknown gender. On 26-AUG-2014, the patient was vaccinated with expired PROQUAD (merck), injection, 0.5 milliliter (ml) once, subcutaneously. Concomitant medications were not reported. No adverse effects were reported. Patient did not seek medical attention. The outcome of events was unknown. No product quality complaint (PQC) was involved. No additional information was provided. Additional information has been requested.
Seizures post vaccination on 01/16/2015 and at 12:40 a.m. and 1:27 a.m. on  01/17/2015.  Called 911 on 01/16/2015, but they did not come out as seizure eventually subsided.
Aches; Chills; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN (Aches) and CHILLS (Chills) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Aches) and CHILLS (Chills). At the time of the report, PAIN (Aches) and CHILLS (Chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported.   Reporter did not allow further contact
Received Pfizer Dose for children ages 5-11. Should have received Pfizer dose for patients age 12 and up. No s/s of distress noted
She reports that she received 6 previous Moderna COVID-19 vaccine and she had some side effects.; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (She reports that she received 6 previous Moderna COVID-19 vaccine and she had some side effects.) in a 67-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 030G22B and AS7165B) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (had COVID Disease at the end of the year 2020.) in 2020.   On 13-Oct-2022, the patient received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 27-Mar-2023, received seventh dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (She reports that she received 6 previous Moderna COVID-19 vaccine and she had some side effects.). At the time of the report, IMMUNISATION REACTION (She reports that she received 6 previous Moderna COVID-19 vaccine and she had some side effects.) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. She reports that she received 6 previous Moderna COVID-19 vaccine and she had some side effects. But after receiving Spikevax she had such severe side effects that was worst than COVID disease that she had in 2020 prior to vaccination. Had side effects. worst than COVID Disease. She had  Flu shot on Aug 2023. No treatment medication reported.   This case was linked to MOD-2023-748689, MOD-2023-748694, MOD-2023-748694 (Patient Link).
Constant headache starting the day after the vaccine. Headache is non stop(temporary relief from Tylenol). It increases in intensity when concentrating or doing physical exercise. It's been over 2 and half months.
swolleness on arm; itchiness; rash on arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swolleness on arm), PRURITUS (itchiness) and RASH (rash on arm) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 07-Apr-2021, the patient experienced PERIPHERAL SWELLING (swolleness on arm), PRURITUS (itchiness) and RASH (rash on arm). At the time of the report, PERIPHERAL SWELLING (swolleness on arm), PRURITUS (itchiness) and RASH (rash on arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant drug information was not provided. Treatment included Loratadine was self administered thinking that was some kind of allergic reaction.
I have an underlying condition; the first shot that I took made my condition episodes longer and much more intense; I was extremely fatigued; like not getting out of the bed for days; I had very strong headache; vomiting; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2), administration date 11Mar2021 (Lot number: EN6203, Expiration Date: Jun2021) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: CONDITION AGGRAVATED (non-serious) with onset 11Mar2021, outcome "unknown", described as "I have an underlying condition; the first shot that I took made my condition episodes longer and much more intense"; FATIGUE (non-serious) with onset 11Mar2021, outcome "unknown", described as "I was extremely fatigued; like not getting out of the bed for days"; HEADACHE (non-serious) with onset 11Mar2021, outcome "unknown", described as "I had very strong headache"; VOMITING (non-serious) with onset 11Mar2021, outcome "unknown", described as "vomiting".  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021523905 same patient/drug, different dose/event
Vaccine stored under refrigeration beyond 30 days. Moderna lot number 056m21a maintained the activity neccessary to protect against the SARSCoV-2 (COVID-19) virus at time of administration. Did not contact patient per no action required.
Information has been received from a registered nurse (RN) concerning an elementary aged child who was vaccinated with a dose of VARIVAX (Merck). The RN reported that in February 2006, the patient developed breakthrough chickenpox which was considered to be a light, mild case. Unspecified medical attention was sought. At the time of this report, the outcome was unknown. Additional information has been requested.
palpitations and shortness of breath same day intermittently and daily worse with movement ove rthe last week, also persistent diarrhea nausea and dizziness
REDNESS AT INJECTION SITE; This spontaneous report received from a patient via a company representative concerned an 18 year old female. 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 08-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On APR-2021, the subject experienced redness at injection site. Treatment medications included: diphenhydramine hydrochloride. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from redness at injection site. This report was non-serious. This parent/child case is linked to 20210450484.
pt recv vax 21AUG95 & on 20JAN95 pt devel chickenpox it was reported that two other pt #97021047 & 97021048 who recv varicella vax;
Palpitations and high heart rate beginning in august 2021. Went into primary care in October for HR symptoms and bloodwork showed very elevated T3 and T4 and almost undetectable TSH. TRAB antibodies  positive. Ultrasound showed enlargement of thyroid consistent with thyroiditis. Unable to diagnosis Graves versus thyroiditis at this time. Still breast feeding and cannot do the iodine uptake scan.
Pt recvd vax 3PM & @ 7PM started whinning-given APAP supp @ 10PM & slept 1 hr-woke up fussy & vomited; 6AM-woke up w/fever; not taken until 6PM when it was 102;
Felt medication course through body. 4 days later extensive hip to knee pain requiring ER visit on day 10, followed by visits to doctor and PT. Continued hip and leg weakness with continued treatment with drug therapy.
patient reported she had extra bleeding from shot and felt it was infected because it had white pimple near shot, she did not go to doctor and said she is fine now, but didnt notify us when it happened.
Patient recieved a Proquad  (MMR and Varicella) and a Varicella - instead of an MMR and Varicella
pt recvd vax 22SEP93; pt devel soreness in the arm of inject; w/in 2 days also devel a cough which lasted for 3-4 wks;
Narrative:  COVID infections following completion of COVID vaccine series 03/10/21 COVID vaccine dose #1 03/31/21 COVID vaccine dose #2 04/05/21 COVID swab performed preop - NEGATIVE 07/22/21 Pt reports cough, congestion, headache, dizziness, loss of taste/smell; COVID POSITIVE 07/23/21 Pt reports diarrhea, fatigue, fever, runny nose; rx given for acetaminophen, DM/guaifenesin, loperamide 07/25/21 Pt reports very little cough, improving fatigue, continued loss of taste/smell; "feeling better every day" 07/26/21 Pt reports postnasal drip but is improving
Extremely long, painful, and irregular periods. Sometimes 2 periods in one month. Sometimes period is late. Most recent period has lasted 8 days.
Patient has had pain in the arm since the injections on 4/1/2019 (pain that never went away).  Her dr has done a x-ray (showed  "filling up with arthritis" according to patient) and has a MRI scheduled for 6/20/19.  Complains on loss of mobility and feeling in the arm since the injection (she stated the shingrix specifically).
petechia all over back welts on back and arms sudden weight loss from 175 to 136 in 1 week gout attack in big toe left foot (no history ever) profound fatigue lost taste (still can't taste after 6 months
Patient started having redness in area, bump formed, redness continued to get worse over the course of a few days and spreading around arm, itching and pain.  Patient scheduled to see provider on 2/23/23.  She only came in and informed office of this issue on 2/22/23.
This spontaneous report was received from a physician refers to a 22 month old male patient. On 30-SEP-2013 the patient was vaccinated with a dose of GARDASIL (lot#, expiration date and route not reported). Other suspect therapies included influenza virus vaccine (manufacturer unknown) (lot#, expiration date and route not reported) and VAQTA (lot#, expiration date and route not reported). The patient's father informed the physician that since that date the patient's behavior had changed and became very aggressive. Example of this is that the patient "climbed up on a chair and pulled the television down" on 01-OCT-2013. The patient had also "taken his stool out of his diaper and smeared it on the rug" and "taken eggs out of the refrigerator, cracked them and smeared them all over the floor". The physician also reported that the patient's sleeping patterns had changed and patient woke up at 1 am and tried to feed his younger infant sibling. Outcome of the reported events were unknown. Causality was not reported. Additional information is not expected.
Patient had lung injury NOS needing hospitalization.  AB testing revealed AB to capsid and spike.  she had sx covic 3/2020 and this may be a reaction to prior infection with vaccine or re-infection with covid with negative nose tesitn
Shingles outbreak. Sore arm. Temp 99.4. Fatigue.
Site: Pain at Injection Site-Mild, Systemic: Hypertension, tachycardia, faintness with no loss of conciousness-Severe, Systemic: Hypertension-Severe, Systemic: Shakiness-Medium, Systemic: Tachycardia-Severe, Systemic: Weakness-Medium, Additional Details: BP 5 min after injection 186/100 HR 199
Body temp regulation has been off, I am now always hot and sweaty. Im usually cold and sleep with a heating blanket all year.  now I can't even wear clothes to bed and need a fan or air conditioner on. Also had a very itchy swollen arm, which went away, however it came back exactly week later, I couldn't even move my arm. Also I feel stinging, burning and  itching starting Thursday Thur Friday every week
On May 4, 2023, I felt exhausted, and I had a head cold. It went to my chest in two hours, and I had a fever of 101.7 with lots of coughing. I also have a lot of shortness of breath. I went to the emergency department, and they prescribed cough syrup. I talked to my pulmonologist, and they put me on AUGMENTIN.
This spontaneous report was received from the doctor's nurse regarding a 19-month old patient of unknown gender. The patient's pertinent medical history, concurrent conditions and concomitant therapies were not reported. On 22-OCT-2015,  the patient was vaccinated with the first dose of M-M-R II and second dose on 26-MAY-2016, (dose 0.5 ml, twice) strength, lot # and expiration date were not reported, for prophylaxis (reported as second dose given seven months after the first). No adverse event was reported. This report was not associated with a product quality complaint.
Sore throat; 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 OROPHARYNGEAL PAIN (Sore throat) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Sore throat). At the time of the report, OROPHARYNGEAL PAIN (Sore throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported.
Patient received the Moderna approximately 2 weeks before the 90 day period from her last Remdesivir that was given on 4/24/2021.  Patient was called on Monday, 7/12/21 and she stated that she was doing fine and felt well.  Patient stated that she had a low grade fever and body aches the day after the vaccine, but Tylenol controlled her symptoms.
Got last Pfizer shot and the day after I started having shingles pain!! Was like that for several days before blisters showed up
Pt broke out in hives approx 20 min after vaccine was given (pt did not leave the exam room). Benadryl given 9 ml po.  Hives resolved 15-20 min after Benadryl. Pt acting normal.
This spontaneous report as received from a nurse practitioner refers to a child patient of unknown age. On 29-MAY-2013 the patient was vaccinated with COMVAX (injection, lot # 1513AA, exp date as 06-MAY-2013, strength, dose number, route were unspecified). No adverse effect reported. The outcome was unknown. Additional information has been requested.
administration of menquadfi post excursion with no reported adverse event; Initial information received on 10-Mar-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2023SA082363(CLUSTER) and 2023SA082367(CLUSTER).  This case involves a 15 years old male patient and it was reported administration of meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] post excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitants and family history were not provided.   On 10-Jan-2023, it was reported administration of 0.5 mL of meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] solution for injection (batch/lot number: U7449AB and expiry date: 23-SEP-2024; strength, route: unknown) in unknown administration site for Immunization post excursion with no reported adverse event (poor quality product administered) (latency: same day).  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the event.  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 the 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.; Sender's Comments:  US-SA-2023SA082418:
Immediately a sore arm, under arm soreness, followed by light rash below injection site beginning 02/26/2021. Some joint pain.
swelling underneath the armpit towards the shoulder where they gave the shot; This is a spontaneous report from a contactable consumer. A 58-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 31Jul2021 (at the age of 58-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Reason for no lot number: of COVID Vaccine: caller unwilling to complete the report. The patient medical and concomitant medication history were reported. Other product, patient history and investigation assessment were not provided. Patient had the vaccine 2 days ago and got a swelling underneath the armpit towards the shoulder where they gave the shot. Patient wants to know if this was normal. 2nd dose schedule on 28August2021. The outcome of the event was unknown.   The lot number was not provided. Information on lot number has been requested during follow up.
Around 7:00 pm on November 20th my son had a 103 temp. His voice was hoarse and couldn't talk very well. The next day the 21st my husband called the health dept. where he received his shots and was told to give him Tylenol and that was it.  We continued to monitor him. Gave him Tylenol and Ibuprofen, luke warm baths and let him sleep because he could barely move he was sooo sick.  That evening he was sleeping and I checked on him and he was flopping everywhere and shaking.  My husband rushed him to the ER and we were told he had a seizure. My son was sick for 3 days after that with a fever and cough and a hard time talking.
Shortly after, lightheadedness. Muscle soreness and headache the following 2 days.
Vaccination Nurse administered a pediatric dose of Pfizer(5-11y.o)  to Client who is 12 years old
Case number PHEH2013US021520 is an initial spontaneous report received from a pharmacist on 15 Oct 2013. This report refers to a female patient of an unknown age. On 14 Oct 2013, while she was pregnant, she was administered with FLUVIRIN (batch number: unknown) intramuscularly from a multidose vial. No adverse event was reported following vaccine exposure during pregnancy. Follow up information received on 15 Oct 2013: This case is lost to follow up because the reporter was anonymous.