chrisvoncsefalvay/vaers-outcomes huggingface dataset:
veins became very inflamed and like blood clots/inflammation; there appeared much more varicose veins; The soles of her feet started to burn; feet hurt a lot; her bones hurt; felt really bad; headache; fever; This spontaneous case was reported by a consumer and describes the occurrence of VARICOPHLEBITIS (veins became very inflamed and like blood clots/inflammation), VARICOSE VEIN (there appeared much more varicose veins), BURNING SENSATION (The soles of her feet started to burn), PAIN IN EXTREMITY (feet hurt a lot) and BONE PAIN (her bones hurt) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Varicose veins in 2006, COVID-19 (She had had Covid before the vaccination) and Varicose vein operation NOS (he had various surgeries for Varicose veins).   On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced VARICOPHLEBITIS (veins became very inflamed and like blood clots/inflammation), VARICOSE VEIN (there appeared much more varicose veins), BURNING SENSATION (The soles of her feet started to burn), PAIN IN EXTREMITY (feet hurt a lot), BONE PAIN (her bones hurt), FEELING ABNORMAL (felt really bad), HEADACHE (headache) and PYREXIA (fever). In 2021, BONE PAIN (her bones hurt), FEELING ABNORMAL (felt really bad), HEADACHE (headache) and PYREXIA (fever) had resolved. At the time of the report, VARICOPHLEBITIS (veins became very inflamed and like blood clots/inflammation), VARICOSE VEIN (there appeared much more varicose veins), BURNING SENSATION (The soles of her feet started to burn) and PAIN IN EXTREMITY (feet hurt a lot) outcome was unknown.            No concomitant medication were provided.  After her second dose her veins became very inflamed and there appeared much more varicose veins and like blood clots. The soles of her feet started to burn. Also when she got the vaccine she felt really bad, she had headache, fever, her bones hurt. This lasted a few days. She had had COVID before the vaccination. Her feet hurt a lot. No treatment information were given.
L arm twitching inside the elbow and bruised yellow; twitching; Lymph nodes of L arm swelling; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TWITCHING (L arm twitching inside the elbow and bruised yellow), MUSCLE TWITCHING (twitching) and LYMPHADENOPATHY (Lymph nodes of L arm swelling) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 030B21A) for COVID-19 vaccination.     patient medical history was not reported.  Concomitant products included MINOCYCLINE and CURCUMA LONGA (TURMERIC CURCUMIN [CURCUMA LONGA]) for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MUSCLE TWITCHING (L arm twitching inside the elbow and bruised yellow), MUSCLE TWITCHING (twitching) and LYMPHADENOPATHY (Lymph nodes of L arm swelling). At the time of the report, MUSCLE TWITCHING (L arm twitching inside the elbow and bruised yellow), MUSCLE TWITCHING (twitching) and LYMPHADENOPATHY (Lymph nodes of L arm swelling) outcome was unknown.            patient medical history was not reported.  Concomitant products included MINOCYCLINE and CURCUMA LONGA  no treatment medications were reported   This case was linked to MOD-2021-273942 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Significant follow-up received. Patient date of birth was updated. 2nd dose Batch no was updated. Event verbatim was updated to twitching.
Patient arrived at pop up clinic by County Public Health on 2/9/2023. Per her CDC record, she had received a Pfizer dose (lot and type unspecified) on her CDC card. Shot was given on 11/4/2022 from Facility. When comparing to her record, which also confirmed no other history of COVID-19 vaccine, she had received on 11/4/2022 a Pfizer Bivalent with Lot # GJ5342 given by staff at Facility. Her follow-up date on the back of the CDC  card also stated 2/4/2023. Per CDC guidelines, that was considered a vaccine administration error and we continued her series with her receiving her second monovalent Pfizer dose on 2/9/2023 with Lot #FR2587. Patient didn't note any adverse reactions after her first shot. She was monitored for 15 minutes post-vaccination without any complaints.
Patient said her whole upper arm was red and swollen. It was not hot. She also said her arm hurt. The injection was given on Sunday the 8th. The reaction was there when she woke up on the 9th and was gone on the the 11th.
Day after injection, lots of swelling at injection site, swelling in armpit and left breast swollen after the 3rd injection.  Left arm very painful/sore after 3rd injection for 4 days with swelling in above areas lasting for 4 days.  Also have not had a period since 3rd injection which is not at all normal for me. 1 week after vaccination, had severe migraine with increase in BP.
Got flu shot at pharmacy and began feeling unwell. After receiving flu shot, he went out to the car while his wife receive her flu shot. When wife returned to car, patient unresponsive and apneic.  Estimated down time 5 minutes. No associated trauma. EMS performed CPR and epinephrine administered.  Patient resuscitated but remained unresponsive throughout hospitalization. Patient died on 9/23/21 at 14:20.
Anaphylaxis: patient apparently had c/o abdominal pain and "throat hurt" while leaving the office, skin flushing, hives, cough.
Patient received the pediatric (5-11 year old) Pfizer vaccine dose .  PCP informed patient of the vaccine error. Patient scheduled an appointment to repeat the 2nd booster dose.
Pt vaccinated with DTP/HIB/OPV post immunization began to cry, became irritable w/loud shrilling cry, went limp & pale for a brief time, low grade temp. On exam small erythematous lump on lt thigh. Very lengthy report- see WORM.
This spontaneous report as received from a nurse refers to a 40 year old female patient. No information about medical history, drug reactions and allergies was specified. Nurse stated that a pharmacist was administering ZOSTAVAX (lot #, expiry unknown, dose unspecified) on 08-SEP-2014 to an unspecified patient and the ZOSTAVAX accidentally "shot into the pharmacist's face". No concomitant medications were reported. The pharmacist is complaining that she developed blisters on her face on an unspecified date. The pharmacist was seen by her unspecified family doctor regarding the blisters on an unspecified date. The family doctor "did an unspecified culture on the blisters" on an unspecified date. No lab results have been provided. Varicella zoster virus (VZV) packet offered and sent. On 25-SEP-2014 at 09:30, the pharmacist, was going to be examined for a specimen collection of fluid-filled vesicles on her face. Attempted to connect the nurse to VZVID contacts for guidance on appropriate materials to use for specimen collection for VZVID. On 25-SEP-2014 at 15:39, nurse called to provide additional adverse event information. Nurse stated that the correct information as to what occurred on 08-SEP02014. She stated that the pharmacist was withdrawing the ZOSTAVAX vaccine from the vial before giving to the patient and the vaccine went onto her left hand not her face. The pharmacist developed small lacerations on her left hand and not her face. On 30-SEP-2014, the nurse stated that the patient is coming back to the office today, reporting that she has additional vesicles on her face. The nurse is inquiring if she should collect additional specimen samples to send to for testing for VZV. She inquired, how soon will the results be available from the specimen I sent to the lab. VZV packet re-faxed to the nurse. Left a voicemail message for the Clinical Safety Risk Management (CSRM) representative, and this service request will be e-mailed to the department and nurse would be called. On 06-OCT-2014, nurse reported that the patient continues to have new breakout lesions. Unspecified where the new lesions are located. The patient would be coming to the office tomorrow (07-OCT-2014) for an appointment. No intervention was done to prevent serious criteria as there was none. There was no product quality complaint. The outcome of the events was reported as not recovered/not resolved. The causality of the events was not reported. Additional information has been requested.
immunocompromised patient received a 3rd dose of 0.25ml instead of a 0.5ml dose; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (immunocompromised patient received a 3rd dose of 0.25ml instead of a 0.5ml dose) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced UNDERDOSE (immunocompromised patient received a 3rd dose of 0.25ml instead of a 0.5ml dose). At the time of the report, UNDERDOSE (immunocompromised patient received a 3rd dose of 0.25ml instead of a 0.5ml dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication and treatment drug were reported.   Most recent FOLLOW-UP information incorporated above includes: On 16-Mar-2022: Follow up document contain no new information.
Injection site pain; Injection site numbness; Initial information received on 13-Feb-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves an female patient who experienced injection site pain (vaccination site pain) and injection site numbness (vaccination site hypoaesthesia), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UJ212AB (Expiry date unknown) via unknown route in unknown administration site for Prophylactic vaccination.  On  13-Feb-2020, the patient developed a non-serious injection site pain (vaccination site pain) and injection site numbness (vaccination site hypoaesthesia) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Final diagnosis was Vaccination site hypoesthesia and Vaccination site pain.   It was not reported if the patient received a corrective treatment.  The event outcome is reported as Unknown for Vaccination site hypoesthesia and Vaccination site pain.
Mood swings; Nausea; Headache; On 10 Apr 2021 received 1st dose, on 10 Oct 2021 received 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of MOOD SWINGS (Mood swings), HEADACHE (Headache), NAUSEA (Nausea) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (On 10 Apr 2021 received 1st dose, on 10 Oct 2021 received 2nd dose) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    The patient had no known allergies.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose once a week. On 10-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (On 10 Apr 2021 received 1st dose, on 10 Oct 2021 received 2nd dose). On 27-Oct-2021, the patient experienced HEADACHE (Headache). On an unknown date, the patient experienced MOOD SWINGS (Mood swings) and NAUSEA (Nausea). At the time of the report, MOOD SWINGS (Mood swings), HEADACHE (Headache) and NAUSEA (Nausea) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (On 10 Apr 2021 received 1st dose, on 10 Oct 2021 received 2nd dose) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported. The reporter's causality for the event of headache with Humira was reported as reasonable possibility. The reporter's causality for the events of nausea and mood swings with Humira was not provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (soreness at injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     Concomitant products included CALCIUM and CALENDULA OFFICINALIS, GINKGO BILOBA, SOLANUM LYCOPERSICUM, VACCINIUM MYRTILLUS (EYE HEALTH) for Supplementation therapy.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PAIN (soreness at injection site). At the time of the report, INJECTION SITE PAIN (soreness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication includes Cholesterol medication  Treatment medication was not provided by the reporter.   This case was linked to MOD-2021-403387, MOD-2021-403392 (Patient Link).
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 17-JUN-2016, the patient was inoculated at a pharmacy with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. Later in 2016, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving zoster vaccine live ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events is unknown. Additional information has been requested.
After 1 minute after I injected the vaccine into her left arm 1 inch apart from the Tdap Vaccine (Boostrix) she started having a reaction to the vaccine. I was going to inject the MMR vaccine into her right arm as she was getting 3 vaccines in total. She first said she wasn't feeling well and then her face turned white and her eyes opened wide and she said she feels nauseous. I asked her to stay seated and breathe and then she said that she cannot see anymore. I told her that I am going to call 911 and she initially said no and then she stopped breathing while still awake, her ribcage was not moving and she stopped responding and her husband told me it is okay to call 911. I called them and while they were on the way, her husband and I had to talk to her and shake her under she drew a breath every 1 minute. I had the EPIPEN ready incase she totally stopped breathing. The paramedics came and took her vital signs and said that all her vitals are low and she needs to go to the hospital but she refused as she didn't have insurance. They put an oxygen mask on her and she started to feel better. After 15 minutes from the start of the reaction, she was responsive again and left the store. I refused to give her the third vaccine even though she insisted to take it. I called the patient later on the day and the next day to check on her and her husband picked up and said she was doing fine.
Erythematous nodule app 0.5 cm in diam both thighs.
Localized redness on arm. Hot to the touch. Patient stated it was "itchy." Patient was seen on 2/23/2018; by this date the redness had minimized significantly and it was not painful. Parents put over the counter BENADRYL lotion to help with the itching on 2/22/2018. Dr. prescribed ATARAX 6ml PO Q6H PRN for itching.
Really bad headache; Fever; Nausea; Upset stomach; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect, received from a contactable consumer (patient). A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, via an unspecified route of administration on 25Jan2021 at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got her second dose of vaccine on 25Jan2021 and that night she experienced really bad headache, fever, nausea, and upset stomach on 25Jan2021. She was still having these symptoms and wanted to know if this was normal. Outcome of the events was not recovered.    Information about batch/lot number has been requested.
I've since been diagnosed with Pars Planitis by Dr. with no discernable cause. I reported this on my other report. Check-In and a representative from other report contacted to tell me I should fill out this form. I noticed a buildup of floaters and constant flashing lights in my left eye, which was caused by a tear in my Retina. After being treated by Dr, it was discovered that I had a lot of inflammation around my retina, which is responsible for the disruption to my vision. I was treated with Durazol, which I was revealed to be intolerant to and began to see even more disruptions to the vision in my left eye, which revealed that my eye pressure was building. This was treated with Brimonidine and Dorzolamide, but my intolerance to Durazol is too severe to treat the inflammation.  Treatment ongoing.
Asymptomatic for observation period after vaccine. 40min after vaccine developed itching feeling in through and then reported feeling of "throat closing and lump in throat." Immediately returned to office for prompt evaluation. All vital signs normal, SPO2 98%. Relaxed breathing with clear lung sounds. No stridor or wheezing. left soft palate arch slightly lower than right but not visible swelling to tongue to lips. No rash. No GI symptoms or dizziness. Swallowing water well, no drooling.  50mg Benadryl provided with resolution of itching in throat. Still reported a lump in throat but no acute distress. Denied anxiety as a cause. Discussed epipen, but no visible evidence of distress so it was not administered in office. After continued observation, mother who is an RN agreed to take her home for observation.  Aware to call 911 for ED eval for any respiratory symptoms/worsening.
07/26/17 Pt. c/o feeling achy that evening. 07/27/17 Pt. c/o injection site being swollen, red, warm, and tender. 07/28/17 Pt. reports arm being less sore, but still swollen, red, and warm. 07/31/17 Pt. reports symptoms are resolved - Pt. took BENADRYL and TYLENOL.
Patient came to pharmacy on 9/15/12 to show us her right arm where she had received ZOSTAVAX. Her arm was red around injection site 2" diameter area. Complained of ache in RT. shoulder.
Adverse effects started 9 hours after injection. Skin, all over body, felt like it was on fire when touched. This lasted for about 10 hours. Chills lasting for about 10 hours. Severe aches and pains in joints and muscles lasting for about 42 hours then diminished. Light headache lasting about 28 hours. Extreme fatigue and overall weakness lasting about 28 hours.
Grandma was Changing his diaper around noon on 10/21/2017 and noticed a small pimple like bump on thigh no redness, warmth or noticeable pain. As the day went on she noticed at about 3:30 there was some redness surrounding injection site. At about 7:30 she noticed area was very red, swollen, and warm to the touch which they then presented to ER and patient was checked out. They assumed it was a hematoma and released. At about 10:30 that night they noticed rash had then spread to both arms and was worse at injection site, they returned to ER and was admitted, had Xray and blood work done. ER doctor had considered transferring him to burn unit, but decided at that time against it. After a while he was transferred to be evaluated by pediatric doctor, which finding where allergic reaction to unknown substance, unable to rule vaccine out as cause. Patient followed up in PCP's office today 10/23/2017 and rash still present at injection site and a couple spots on face. Was treated with steroids.
Patient had hives week after getting first SHINGRIX shot and and problem is still going on. According to patient they are oozing with oily stuff and keep moving from one body part to other.
Sore arm extending up to neck; Sore arm extending up to neck; fatigue; This is a spontaneous report from a contactable nurse reporting for herself.  A 57-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in the left arm on 25Feb2021 at 12:30 (at the age of 57 years old) (Batch/Lot Number: EL3247) as a single dose for COVID-19 immunisation.  Medical history included sjogren's syndrome from an unknown date, breast cancer female with radiation from an unknown date, cholecystectomy from an unknown date, right knee arthroscopic surgery for chondromalacia from an unknown date, bilaterial fusion L4/L5 from an unknown date, vertigo from an unknown date, and allergy to bee sting from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication(s) included hydroxychloroquine sulfate (PLAQUENIL) taken for an unspecified indication, start and stop date were not reported; vitamin d nos (VITAMIN D NOS) taken for an unspecified indication, start and stop date were not reported; berberis vulgaris root, camellia sinensis leaf extract, coptis chinensis root, curcuma longa rhizome, fallopia japonica root with rhizome, origanum vulgare leaf, rosmarinus officinalis leaf, scutellaria baicalensis root, zingiber officinale rhizome (ZYFLAMEND) taken for an unspecified indication, start and stop date were not reported; glucosamine (GLUCOSAMINE) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced sore arm extending up to neck on 25Feb2021 at 17:00 with outcome of recovering, and fatigue on 25Feb2021 at 17:00 with outcome of recovering. Treatment was not received for the events. It was also reported that since the vaccination, the patient had not been tested for COVID-19.