chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I woke up with a menstrual period kind of pain but I dont have periods; It felt like bloating; This is a spontaneous report from a non-contactable consumer, the patient. A 49-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 03Apr2021 at 01:30 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism and penicillin allergy. The patient received unspecified medication within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 04Apr2021 at 08:00 the patient woke up with a menstrual period kind of pain(menustral pain), it felt like bloating (bloating) and menstrual pain. She did not had periods since 3 years ago. Therapeutic measures were taken as a result of bloating and menstrual pain which included treatment with ibuprofen. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events menstrual period kind of pain (menustral pain), felt like bloating (bloating) and menstrual pain were recovered on an unknown date in Apr2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
acute onset of pain in right knee, low back, swelling back of right knee. onset of numbness down right leg, especially lower posterior and right foot.
Initial unsolicited report received from the literature on 9 August 2015. The following is verbatim from the article: Background: Mechanisms underlying poor Ab responses to vaccines in well controlled HIV infected patients are not fully understood. In this study we have examined the role of a novel subset, the peripheral T follicular helper cells (pTFH) in Ab production. Methods: The study was conducted in cryopreserved cells of 16 HIV infected, ART-treated individuals and 8 healthy donors (HD) who had been given a single dose of H1N1/09 influenza vaccine in 2009. Only 8 of the 16 patients and all HD had a flu-Ab response at 4 weeks post vaccination. Vaccine responder (VR) and non-responder (VNR) patients were equivalent in mean age, viral load, CD4 and CD8 T band B cells. B (CD20 plus) and TFH (CD3 plus CD4 plus CD45RA- CXCR5 plus) cells were purified by cell sorting on a FACS ARIA and co-cultured. IgG levels in culture supernatants were determined by ELISA. B and T cell phenotypic analysis was performed by multicolor flow cytometry. Differences between groups were analyzed by Student t-test or the 2-sample Wilcoxon rank-sum (Mann-Whitney) test. Results: Frequency of pTFH was equivalent in HIV positive patients and HD before vaccination. pTFH cells underwent significant expansion at week 4 compared to baseline in VR patients (p equal to 0.003) and HD (p equal to 0.001) with increased frequency of Ki67plus cells. In VR, H1N1-specific IgG production was evident in CD4 plus CXCR5 plus /B cell co -cultures but not in CD3 plus CXCR5-/ B cell co-cultures [HIV positive n equal to 3; p equal to 0.043] and [HD n equal to 3; p equal to 0.014], concurrently with increase in frequencies of plasmablasts. These changes were not seen in vaccine non responders. Conclusion: pTFH cells promote antigen-specific Ab production by B cells in vitro. Although their relationship to lymph node germinal center TFH has not been clarified, analysis of pTFH function represents a novel and easily accessible surrogate marker for vaccine responsiveness in stable HIV infected patients with equivalent CD4 T cells. This case involves an eight patients (age and gender not reported) those were vaccinated with a dose of INFLUENZA vaccine (batch number, dose route and site of administration was not reported) on an unspecified date in 2009. All patients had a medical history of HIV infection. Concomitant medications were not reported. On an unspecified date, following the vaccination, patients were not showing Ab (antibody) response. Relevant laboratory test results included antibody test (immunoglobulin G) negative and IgG levels in culture supernatants were determined by ELISA. Corrective treatments were not reported. Outcome of event was unknown. Documents held by sender: none.
been in bed for two days after second dose of vaccine; 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 BEDRIDDEN (been in bed for two days after second dose of vaccine) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BEDRIDDEN (been in bed for two days after second dose of vaccine). At the time of the report, BEDRIDDEN (been in bed for two days after second dose of vaccine) outcome was unknown.            No concomitant medication provided by the reporter no treatment information reported by the reporter
Transfer from outside hospital with  petechial rash. At ED, lab showed thrombocytopenia.
AE's : Injection tenderness, fever, chills, headache, malaise, severe myalgia, lymphadenopathy, mild sore throat, occasional nausea and lightheadedness when standing for longer than 5-10 minutes at a time.  Tx: none Outcome: All AE's except injection tenderness and right axial lymphadenopathy fully resolved within 48 hours.
Patient  of complained of itching near injection site and a feeling of "throat swelling" and chest discomfort approximately 30 minutes after recieving vaccine. No medications were admistered by physician.
On 02/03, at 01:15PM and 01:30PM, I started to have spinning occur in my right eye. On 03/02, I had the spinning occur in both eyes at 07:15AM and 07:35AM. I received my second dose that morning at 10:00AM. On 03/06, I had the spinning occur in my left eye only at 09:55PM and 10:05PM. On 03/08, at 08:38AM and 08:47AM I had the spinning occur in my left eye only. I sought care from my doctor, at an eye care center, on 03/05. He diagnosed me with Ocular Migraines. I had one more episode occur on 03/09 at 07:15AM and 07:25AM in my right eye.
One day after immunization, child developed redness and swelling of R deltoid are. Came to office and was prescribed ZURTEC prn and Cephalexin.
Patient reports rash development ~2 weeks after receiving first dose of Moderna COVID-19 vaccine. patient reports rash began on upper arms/shoulders near injection site and progressed to other areas of body including torso, legs, and arms.
refrigerator door was left open. Products were exposed to a maximum of 57.2 degree Fahrenheit for a duration of 12 hours with no adverse event; Initial information received on 07-Oct-2021 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves no identifiable patient and it was reported that refrigerator door was left open. products were exposed to a maximum of 57.2 degree Fahrenheit for a duration of 12 hours with no adverse event (product storage error).  Product included:  Insulin glargine [Toujeo] (batch number and expiry date unknown).   On an unknown date (latency unknown), it was reported that a refrigerator door was left open. Products were exposed to a maximum of 57.2 degree Fahrenheit for a duration of 12 hours (product storage error).  Action taken with suspect drug was not applicable.  No corrective treatment was received.  At the time of report, event outcome was unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  There will be no information available on the batch number for this case   No further relevant information was reported
There is a knot/nodule between the armpits and arm; Armpits on the left side are swollen; The injection site is red and swollen; The injection site is red and swollen; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Aug-2021 and was forwarded to Moderna on 25-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of NODULE (There is a knot/nodule between the armpits and arm), SWELLING (Armpits on the left side are swollen), VACCINATION SITE ERYTHEMA (The injection site is red and swollen) and VACCINATION SITE SWELLING (The injection site is red and swollen) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004F21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 and Sickness. Concurrent medical conditions included Rheumatoid arthritis.    On 21-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced SWELLING (Armpits on the left side are swollen), VACCINATION SITE ERYTHEMA (The injection site is red and swollen) and VACCINATION SITE SWELLING (The injection site is red and swollen). On an unknown date, the patient experienced NODULE (There is a knot/nodule between the armpits and arm). The patient was treated with PARACETAMOL (TYLENOL) for Nodule, Swelling, Vaccination site erythema and Vaccination site swelling, at an unspecified dose and frequency. At the time of the report, NODULE (There is a knot/nodule between the armpits and arm) and SWELLING (Armpits on the left side are swollen) had not resolved and VACCINATION SITE ERYTHEMA (The injection site is red and swollen) and VACCINATION SITE SWELLING (The injection site is red and swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.She stated that she takes several medications but does not provide additional details
Extreme exhaustion, chills, muscle aches, brain fogginess, headache - all the symptoms I experienced when I had COVID-19 in early November 2020. All symptoms improved within 18 hours except headache, which lasted for 36 hours. Headache was also a lingering effect after all other COVID-19 symptoms subsided when I had the virus, as well.
This is not a request.  I received the current flu vaccine at a local pharmacy on 24 September at 2 pm, with no warning that the vaccine is grown in an antibiotic medium.  Within 24 hours, I experienced a rash, intense itching, swelling, extreme fatigue and slight asthma (which could have been life threatening), necessitating intervention treatments kept on hand for emergencies, including hydrocortisone.  I have not fully recovered yet. I am severely allergic to some antibiotics, specifically Penicillin. A pharmacist provided information about the antibiotic medium as an ingredient at 4 a m. A warning should be available to others.  I doubt that I am the only recipient to experience such a reaction.
After the vaccination the pt. wait for 15 min,  during the wait parent  stated the pt. is not feeling well. Parent stated pt. have vision trouble and feel dizzy.  I call emergency services. When the paramedic arrive, they examine the pt.  Slowly the pt vision and dizzy improve.
"rt deltoid muscle large ant swelling reddened;started 18hr later, p/vax, t102, now 97;given APAP;suggested DPH ice to arm cont APAP;"
Patient stated that he felt dizzy and was sweaty. Patient was sitting on the floor. Patient had water and peanut butter crackers and stated to feel better after that. BP 126/88 and 54 HR
Covid or Moderna arm Hard, painful, red, swollen lesion around injection site Still evident five days after injection Cold compresses?mild relief of pain
Headache like head pulsing; Dizziness; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date not reported), via an unspecified route of administration in left arm on 10Jun2021 at 00:30 (at the age of 33-year-old) at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: unknown) via an unspecified route of administration in left arm on 13May2021 (at the age of 33-year-old) at single dose for COVID-19 immunisation. On 12Jun2021 at 08:30, the patient experienced headache like head was pulsing and dizziness. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events was not recovered.  The lot number for BNT162b2 was not provided and will be requested during follow up.
On March 27, 2021 I got a 102 that night and the fever lasted for 48 hours and there was body pain and after the fever broke I got the covid arm. I didn't call the doctor until three months later and that is when I got the blood clot, on Monday June 13, 2021. I also went to the urgent care: immediate care at the Hospital, the same day, June 13, 2021 because their was a pain in my right hand underneath the thumb and I couldn't move it at all.  In the urgent they said it could be that my joints were swollen and they gave medication/shot in my buttocks: Toradol. After that, that night a hemorrhage appeared. I called my Dr. and she gave me an appointment on Friday, June 18, 2021. She said that it could have been a clot and wanted further imaging and my appointment is this Friday, July 2, 2021.
2nd vaccine adverser events: fever, chills, shakes, muscle cramps, headache, nausea, dizziness, tiredness
Grandma reports pt had edema @ inject sites, fever to 103.6 R several hrs, limp & dehydrated, congested, cough, lethargic, would not eat or drink; Given APAP; Seen in ER dx allergic rxn to shots & unk virus;
Patient presented to clinic for appointment to receive her second shingrix vaccine.  Vaccine was given following proper procedure.  Patient called clinic 48 hours later on 4/28/2022 at 8:45am and stated that she was concerned about her vaccine site.  She states that the day of the vaccine her arm hurt as she expected from the vaccine but then it didn't go away.  She states the next day that she noticed her arm was sore, slightly swollen, and painful.  The following day (this morning 4/28/22) she woke up and her arm was still painful and swollen so she looked at her arm and she noticed that she had red marks or blotches on the back side of her arm.  She decided to call us and see if this was normal or what we thought.  She was encouraged to have her arm evaluated by a physician.  She stated that she would call her PCP at her clinic and see if they could get her in to be seen.
Swollen salivary glands and fever 9 days after getting second MMR vaccine. Illness lasted 5-6 days.
The patient received vaccine after improper storage; No other AE; This spontaneous report has been received from an office manager concerning a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.   It was reported the following vaccines were improperly stored and administered to multiple patients (dates of administration were unknown): varicella virus vaccine live (Oka/Merck) (VARIVAX); Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) and Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (all strength, dose, frequency, route, lot number and expiration date were not reported) for prophylaxis. The reporter did not know which vaccines the patient received. The reporter also was not sure about the previous temperature excursion details for the vaccines. No other adverse event was reported.    This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA003202: US-009507513-2108USA003206: US-009507513-2108USA003207:
Broke out in hives; This case was reported by a consumer and described the occurrence of hives in a patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) for prophylaxis.   On an unknown date, the patient received Fluarix Quadrivalent 2019-2020 season at an unknown dose. On an unknown date, less than 2 years after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced hives. On an unknown date, the outcome of the hives was unknown.   It was unknown if the reporter considered the hives to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not provided. The patient was wondering if they could get an ingredient list for the Fluarix flu shot and said that they didn't need all of them. The patient broke out in hives and was told the shots were latex and preservative free. The patient was trying to narrow down on what could have reacted to and hopes this wasn't an inconvenience.
tense muscle on arm right where injection happened. hard ball half of inch big in between neck and shoulder. body ache, headache
Father called hospital this morning about his son regarding frequent episodes of high fever (106 auricular), headache, and nausea usually lasting about 5 days.  Patient received a Varivax immunization on 10-04-07 at doctor's office.  Approximately 2 weeks after receiving the immunization, he developed a high fever and was seen in the doctor's office on 11-16-07, at which time he also had a sore throat.  Patient was again seen in the doctor's office on 12-31-07 with a fever and headache.  At that time he expressed his concern to the doctor that it could be related to his Varivax vaccine.  He called hospital that same day and spoke to an immunization nurse.  She advised him that she would call the doctor's office and ask them to file a Vaccine Adverse Event Report.  On 1/2/2008 she was able to speak to the doctor, who said she would file a VAERS report.  She faxed a VAERS form to their office for them to use.  Father's concern today was that his child continues to have episodes of high fever, headache and nausea and was seen in the doctor's office again on 1-22-08.  I talked to the doctor's office today and no report had been filed.  A rapid strep test was done at his visit on 11-16-07, which was negative.  The doctor's diagnosis at that visit was viral syndrome, as was the diagnosis for the 12-31-07 visit.  Patient was not ill the day of the injection, but in June 2006 he had beer diagnosed with an autoimmune disorder.  His father reports that he had previously had episodes of fever and headache, but they did not last as long and the fevers had been more easily controlled.
On Day 8 (Jan 5) at 12 pm, I started to feel achy and having tachycardia with PVCs and went to the emergency room at my hospital. I was released, and went to work the next morning feeling OK. That evening on day eight I got a fever, tachycardia in the 150s, chills. The area on my arm was on fire, red with an area 12 x 9 cm area where the injection was given. My employer made me go back to the ER to have it seen. They prescribed me Benadryl, Pepcid. Fever had stopped.
pt recvd MMR vax & following vax pt devel a t103-104 that lasted for a few dasy & resolved; no further details were provided;
Red lesions on back and abdomen, feels warm, complains of nausea.  Symptoms began 10-17-06.
This spontaneous report as received from a pharmacist via a company representative refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with live ZOSTAVAX (lot # not reported). The patient developed swelling around the lips underneath the nose a year later from the date of her vaccination. The patient sought for medical attention by going to the pharmacist. The outcome of swelling around the lips underneath the nose was unknown. The relatedness for swelling around the lips underneath the nose was unknown for live ZOSTAVAX. Additional information has been requested.
CHANGED SINCE GETTING JAB (VACCINE); This spontaneous report received from a consumer 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, and batch number were not reported) dose, start therapy date were not reported 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 an unspecified date, the patient experienced changed since getting jab (vaccine). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of changed since getting jab (vaccine) was not reported. This report was non-serious. This case, from the same reporter is linked to 20220224739 and 20220227232.  Version created to amend previously reported information on 09-FEB-2022. Upon review the following information was amended: Amendment Adverse Event (the case validity assessment was updated to valid from the previously incorrect assessment of non-valid).
Laid down approximately 4pm on Monday April 19th, 2021 with the intention of taking a brief nap. Woke up thinking that it was still Monday April 19th, 2021. Looked at my cell phone and discovered it was 1pm Tuesday April 20th, 2021. I unintentionally passed out for 21 hours straight and I am still in a daze with serious brain fog.
Swollen face, tongue, high fever, vomit, painful legs. Diagnosed at Emergency Room with Rhabdomyolysis.
pt recv vax & exp vesicles which were described as very mild full n back & trunk & more gen on arms;throat cult done that day negative;pt exp mild varicella;
GARDASIL #3 on 2/10/10. R arm tremors, headache, dizziness began 2/11/10.
COVID vaccine breakthrough case. Pfizer ER8727 3/23/21, EW0150 4/14/21 and Moderna 033H21A 1/12/22.
Patient was around his step brother who got the Covid vaccine. A few days after his brother got the shot, patient started having bad headaches, nose bleeds, lightheadedness, stomach cramps, and bruising all over his legs. Patient did not receive the shot but has been this way ever since being exposed to his brother who did receive it.
pt recv vax; devel redness and swelling; used ice pack; seems to develop bursitis by 10nov96; ibuprofen taken; joint pain and limited ROM continues;
Information has been received from a healthcare worker referring to multiple unspecified patients of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were unknown. On unspecified dates, the patients were vaccinated with improperly stored VARIVAX (dose and route unknown, lot # L013824, expiration date: 21-APR-2017). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.