chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain in left shoulder; tingling and numbness in left index finger; pain disrupted sleep during night; passed out because of the pain on 11/14/2016 and was rushed to emergency room; doctor attributed indicent to pain; no other likely causes found; pain responded to Gabapentin and Prednisone, but returned immediately after stopping Prednisone; nerve study on 11/28/2016 did not reveal cause of problems (althought slight entrapments of median nerve at wrist and of ulnar nerve at elbow were detected); X-ray on 12/14/2016 were negative; problems with left are persist until this day, although sleep disruption is not as bad as earlier on; tingling/slight pain persists.
Second dose administered less than 25 days after the first one; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered less than 25 days after the first one) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059E21A and 002F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 16-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered less than 25 days after the first one). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered less than 25 days after the first one) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication was reported.  No treatment Drug was reported.
Shortly after receiving her COVID Moderna injection (second dose) patient calls clinic c/o breathing difficulties w/asthma tendencies, three unprovoked soft tissue hematomas (unprovoked) to her upper extremities. Patient's doctor recommended targeting rash with Metronidazole, and oral anti-inflammatory medication doxycycline to slow/stop inflammatory response. Patient symptoms have resolved.
Mom reports that p/immun around MN, pt had an episode of stiffening, breath holding w/eyes closd & color change became red but white around eyes; episode lasted 1-2 minutes per mom; Emergency Med svcs called but did not sent pt to hosp;
HCP is reporting that a dose was administered after 30-day Use By Date.; no adverse event; HCP is reporting that a dose was administered after 30-day Use By Date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP is reporting that a dose was administered after 30-day Use By Date.), PRODUCT STORAGE ERROR (HCP is reporting that a dose was administered after 30-day Use By Date.) and NO ADVERSE EVENT (no adverse event) in a 71-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-May-2023, 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 09-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP is reporting that a dose was administered after 30-day Use By Date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (HCP is reporting that a dose was administered after 30-day Use By Date.) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP is reporting that a dose was administered after 30-day Use By Date.), PRODUCT STORAGE ERROR (HCP is reporting that a dose was administered after 30-day Use By Date.) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (HCP is reporting that a dose was administered after 30-day Use By Date.) and PRODUCT STORAGE ERROR (HCP is reporting that a dose was administered after 30-day Use By Date.).    No concomitant medication was reported. It was reported that the vial was stored in the fridge on 03-Apr-2023. This was the 2nd Bivalent dose for the patient. The dosage text of the suspect product was reported as unknown. No treatment medication was reported.
I had extreme sore throat and fatigue. fever chills sore throat and then I went to the Clinic on the ship to test for COVID-19 which I was positive. I was given Mucinex, and acetaminophen and it didn't really help. They didn't have any other medications to give me. Once off the ship I found a Urgent Careand I was given Molmupiravir  and I can't take Paxlovid because of because of previous illness.  I did start to recover but not until 12 hours later. I was very sick and had to mask up and I vomited and started having issues breathing. I was taken by an ambulance to to the local hospital I was admitted and stayed for 24 hours and released the next day. I was dehydrated and I was given a IV and monitored for the next 24 hours. When I was released, I was feeling 75% better but still very tired and not wanting to do too much.  I was able to eat but still couldn't smell and I still felt sick.
Large swollen very itchy bumps all over my right arm not just the shot area.  The bumps are still there a week later
Itchy on injection site; Red on injection site; Hard to touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy on injection site), VACCINATION SITE ERYTHEMA (Red on injection site) and VACCINATION SITE INDURATION (Hard to touch) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 27-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy on injection site), VACCINATION SITE ERYTHEMA (Red on injection site) and VACCINATION SITE INDURATION (Hard to touch). At the time of the report, VACCINATION SITE PRURITUS (Itchy on injection site), VACCINATION SITE ERYTHEMA (Red on injection site) and VACCINATION SITE INDURATION (Hard to touch) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported.  Treatment for the event include hydrocortisone 1%.
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 10-DEC-2018, the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # R001084, expiration date 07-NOV-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
Client received the flu shot. Answered no to all screening questions. Never had a reaction to the flu shot before. Client had hives about an hour after her flu shot. She had itching and raised bumps on her neck and arms. Itching was reported on scalp as well. Client declined any itching/swelling of throat/lips/tongue/mouth or face. Client declined benadryl. Client had other allergy medicine on hand to take. Followed up with client the next day, is doing well.
The excursion expiration date of 7 days was thawed in refrigerator was followed because of the Pfizer email approving the 7 days. Walgreens policy was to follow  the expiration of 5 days.
She was quite sick, dizzy, went to ER three times between Saturday and Sunday, they sent her home each time, she died Monday morning.
Strong and uncontrollable Shakiness by 8:30 PM. 38.5 degrees by 11:30 PM on March 5. Strong headache by the next day all morning till 11:00 AM. Fever around 37.5 degrees. On the afternoon started diarrhea and temp started going down till the 36.5 around 8:00 PM. On Sunday all the symptoms disappeared and started a light pain in the arm, like a hematoma, lasted two days, it was light and I was able to move the arm.
Pt admitted on 8/3/2021 with c/o sob, cough, fever. Pulse Ox in upper 80's. J and J covid vaccination completed. Tested on 7/28 and was positive with COVID.  Pt continues to be inpatient at this time.
I have constant tinnitus since about a day after receiving the first dose to the Covid-19 vaccine.  It got worse over the New Year's weekend, and now seems to be stabilized as a constant ringing.  I will be making an appointment this coming week to have it investigated, but wanted to get the preliminary information to you. I have experienced a much lesser degree of tinnitus in the past, always a momentary transient event, not nearly as loud as I am currently experiencing.
Received the 1st injection on Friday. That evening started noticing redness and arm was tender. Wasn't worried because I expected this. On Saturday noticed that the redness was spreading and shot site was very warm, painful to the touch and swollen. Sunday redness has spread even more, still very painful to touch, swollen and hot feeling.  Today, Monday, site still red, hot, swollen and has gotten bigger. Still painful to the touch. I have documented with pictures.
Headache; This is a spontaneous report from a contactable consumer. This consumer reported for a 15-year-old female patient (reporter's Daughter) received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0191 and expiry date was not reported), via an unspecified route of administration, in Arm Right, on 04Jun2021 (age at vaccination: 15 years), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, in Arm Right on 14May2021 (age at vaccination: 15 years), as a single dose for COVID-19 immunization. On an unspecified date, the patient has been experiencing headache everyday since that injection. The reporter asked was that something that was normal or should the headaches have gone away. The patient received Tylenol as treatment for the event. Outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
headache; lightened up on the first 3 days but is still consistent.; menstrual cycle also stopped; chill; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 41 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 03Sep2021 14:00 (Lot number: FC3183) at the age of 41 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "pseudo tumors" (unspecified if ongoing), notes: Note: Caller states that she has pseudotumors. There were no concomitant medications. The following information was reported: HEADACHE (non-serious) with onset 03Sep2021, outcome "not recovered", described as "headache"; DIZZINESS (non-serious) with onset 03Sep2021, outcome "unknown", described as "lightened up on the first 3 days but is still consistent."; MENSTRUAL DISORDER (non-serious) with onset 03Sep2021, outcome "unknown", described as "menstrual cycle also stopped"; CHILLS (non-serious) with onset 03Sep2021, outcome "unknown", described as "chill". Therapeutic measures were taken as a result of headache.  Additional information: Vaccination Facility Type: Pharmacy. Prior Vaccinations within 4 weeks: None. AE(s) following prior vaccinations: None. Family Medical History Relevant to AE(s): None. History of all previous immunization with the Pfizer vaccine considered as suspect: None. Additional Vaccines Administered on Same Date of the Pfizer Suspect: None. AE(s) require a visit to Emergency Room and Physician Office: No. Called nurse hotline. Relevant Tests: None. Patient wanted to know how long they last as she has a residual headache that won't go way. She Stated that she has a high pain tolerance, it was more so annoying and won't go anywhere, not throbbing or aching, it was just there. Treatment taken with Tylenol Arthritis 650mg each. Serious: No. Investigation Assessment: No.  No follow-up attempts are possible. No further information is expected.
it broke all the capillaries in my body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 61-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) at the age of 61 years for covid-19 immunisation; hydroxychloroquine (HYDROXYCHLOROQUINE). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CAPILLARY DISORDER (non-serious), outcome "unknown", described as "it broke all the capillaries in my body". The action taken for hydroxychloroquine was unknown.  Additional information: Reporter stated Twice I've gotten the vaccine. The first one I was on Methotrexate, and it didn't mix with that, it inflamed my lungs and I was on oxygen for a year. The second one I was on hydroxychloroquine, and it broke all the capillaries in my body. So, I had to go off both. I just want to make sure that if I get another vaccination that it's not going to do something horrendous.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
No adverse reactions noted. Resident was given booster covid vaccine 3 days after initial dose in error.
Evening after receiving the flu shot pt developed a fever of 103 degrees F. This lasted through the night with some residual fever the following morning.
I feel like I have the flu. No fever, but I have body aches. Everything hurts, especially my right arm where the vaccine was injected. I also developed welts around the injection site and in addition I am getting a red rash developing down my arm.
a significant headache this morning with pain focused at the front of her head; Weak feeling; feelings of weakness in her legs when walking; sore throat; This is a spontaneous report from a contactable consumer. A 68-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9263) solution for injection, intramuscular on left deltoid on 26Jan2021 at single dose for COVID-19 immunization. Medical history included high blood pressure. Concomitant medication was reported as none. The patient received the first dose of COVID vaccine on 26Jan2021 and reported a significant headache this morning with pain focused at the front of her head after she was up for a while, she also had a weak feeling, feelings of weakness in her legs when walking and a sore throat, all on 02Feb2021. Her headache was very bad, but after treating with 2 tablets of extra strength paracetamol (TYLENOL) 500 mg, her headache was not as bad as it was. This happened suddenly. Her sore throat started the same time as the headache which was currently gone. She wanted to know if these events could be from the vaccine, a week later; if she should get a COVID test; and how long will the headache last if it came back. The outcome of the headache was recovering and recovered on 02Feb2021 for all other events.
I have experienced light dizziness the first day (3/24) Today (3/25) I am unsure on my feet and have not been able to keep anything on my stomach. At first, I attributed this to a weight management plan that I am on, but late recalled the symptom described in my covid response reporting texts.  I Have yet to receive a Covid update text today, so I am submitting this report.  I am scheduled to see my PCP tomorrow.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 02-APR-2014, the patient was inoculated with the ZOSTAVAX vaccine at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 28-JUL-2016, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving 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 was unknown.  Causality assessment was related. Additional information has been requested.
Had the Vaccine on Thursday afternoon. Had a fever of 100.5 Friday morning. Fevers lasted until Sunday Night. Stayed around 99.5 to 100.5. Developed a dry cough on Saturday that is tapering today (Tuesday). Poor appetite thru the weekend. Shortness of breath thru the weekend. Lower back pain.
glands in the neck were completely swollen; had a clogged ear with fluid; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (glands in the neck were completely swollen) and EAR CONGESTION (had a clogged ear with fluid) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 23-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced LYMPHADENOPATHY (glands in the neck were completely swollen) and EAR CONGESTION (had a clogged ear with fluid). At the time of the report, LYMPHADENOPATHY (glands in the neck were completely swollen) and EAR CONGESTION (had a clogged ear with fluid) outcome was unknown.            The action taken was assessed as not applicable since the patient had already taken the second dose. No concomitant drugs were reported.
Information has been received from a pharmacy technician to an unspecified number of unspecified patients of unknown age and gender. The patient's pertinent medical histories and drug reactions/allergies were not reported. Since 29-JUN-2015, the patients were administered an unspecified number of doses of M-M-R II, (Oka/Merck) PROQUAD and (Oka/Merck) VARIVAX (all doses, lot#, expiration date and route were not reported, which   were reconstituted with improperly stored expired sterile diluent (Merck sterile diluent) (lot # K012002 with expiration date 21-JUN-2017; lot # K016443, with expiration date 12-JUL-2017; lot # K018026 with expiration date 17-AUG-201 and lot # K024557 with expiration date 10-OCT-2017. No adverse effect was reported. Additional information has been requested.
Information was received from a medical assistant referring to multiple unknown patients. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unspecified dates, the patients were administered doses of improperly stored PROQUAD (lot# M012985, expired date 12-SEP-2017, human serum albumin (HSA); lot# M012986, expired date 12-SEP-2017, human serum albumin (HSA); lot# M007960, expired date 15-AUG-2017, recombinant human albumin; lot# M011662, expired date 08-SEP-2017, recombinant human albumin (dose and route unknown). The vaccines were exposed under 8.8 Fahrenheit degree (F) for 30 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 18-OCT-2011 the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 28-DEC-2015 the patient was treated by a physician for the onset of severe vesicular rash accompanied by a weakened immune symptoms, which was diagnosed as severe herpes zoster. As a direct and proximate result of these malfunctions 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. Additional information has been requested.
Approx 8 hours after 2nd dose My knuckle on my right hand started to hurt.  4 hours later a joint in my foot and my lower arm felt extreme pain.  This subsided the next day.  - All normal side effects.  My report is that after the initial pain subsided, 2 knuckles in my right hand and a knuckle in my foot still hurt.  - Badly.  And now I have a ganglia associated with the knuckle on the palm of my right hand.
Pt called 10/23/2020 and stated that she had itching and rash on forehead/back that started after taking flu shot on 10/20/2020.  No other concerning signs or symptoms. She took Benadryl and that rash and itching dissipated and she felt much better.
Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypotension-Medium
Day 1-4  fever, headache fatigue Day 6 -25 sore throat, chest congestion, productive cough,  extreme headaches, excessive sneezing, low-grade fever,  no appetite, mental fog Day 23 started z pack
April 17th, 2021 - Feeling jaw and ear pain in AM. Progressed to severe chest pain, shortness of breath, chest tightness. Went to ER. Elevated Troponins(hi specificity) x 2 over 2 hrs then improved. Pain persisted for hours, Medrol dose pak for 6 days did not improve symptoms. Continued symptoms for over greater than 6 weeks continues to come and go intermittently lasting 15 minutes at a time 5-6 times per week. Not associated with activity or eating. NSAIDs continuously diminish symptoms.