chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After getting vaccine I tested COVID positive two days later; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (After getting vaccine I tested COVID positive two days later) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (After getting vaccine I tested COVID positive two days later). At the time of the report, SARS-COV-2 TEST POSITIVE (After getting vaccine I tested COVID positive two days later) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. No treatment information was provided; Reporter's Comments: Based on the information provided, the natural history of COVID-19 and the established information about the mRNA-1273 vaccine, a causal association between the event of tested COVID positive and the product use is assessed as unlikely. The patient was most likely exposed to the disease prior to vaccination.
Full contents of Moderna 2023-2023 formulation vial administered to patient, thought to be >0.25mL. No adverse events noted following 15 minute monitoring period.
Client received vaccine on Monday January 25 in the am  Phone call from daughter  client started fever and weakness late on Wednesday afternoon. coughing but had been coughing prior to vaccine  Daughter called MD started client on her standard dose of Predinisone   No respiratory distress experienced at this time.  Family will continue to monitor client for any changes  MD aware of status at this time .  MD not sure related to Covid 19 vaccine but felt it needed to be reported.
This was a vaccine error, not an adverse event. The nurse reconstituted  yellow fever with sterile water instead of the sodium chloride. According to CDC and Sanofi Pasteur this renders the vaccine ineffective. Patient notified and aware.
pt recv vax 28OCT95 & 10NOV95 pt devel 3 vesicular lesions on neck,one on abd & 4 to 5 on ankle;also exp diaper problems & was cranky & irritable;did not have a fever;playmate devel vesicular lesions-not vax (WAES95120901)
My first Covid-19 vaccine was on 28th December 2020. My second Covid-19 vaccine was 20th of January 2021. I got arm soreness in my left arm 12 hour after both vaccination. In addition I had other symptoms like headaches, fever (108oF), body pain, fatigue, nausea which lasted about 10-11 days after 2nd shot. After that I had difficulties to move my left arm and could not lift it up or to the sites. Then it changed to non-stop pain in my left arm with difficulties to move the left arm, numbness in fingers (little and ring fingers), shoulder pain, neck pain, extreme pain in head, specially in temple, pain radiating to heart and chest. I was prescribed Voltaren.
PREVNAR was given on 7-7-15 next morning developed chills, fever, and local redness and swelling. Burning pain an warm to touch pt treated with prednisone x 5 days apt made for recheck in 2 days in office.
9 hours after getting the J&J vaccine I had bad chills. My body was shaking and my teeth were chattering despite being bundled under 3 blankets. It lasted about10/15 minutes followed by a headache and body aches. The headache and body aches continued the next day and was treated with Tylenol.
Gave FLUARIX shot at 7:50pm on 10/22. About 10-15 minutes later checked on the patient. She stated that she was feeling "tightness" in her throat. I gave her BENADRYL 25mg A (liquid)at 8:12pm and checked her blood pressure 151/77 pulse 82. Rechecked pt at 8:20pm BP 145/76 pulse 72 and gave another dose of BENADRYL 25 mg (liquid). Continued to monitor pt. At 8:50pm pt stated that she feels "at 75%". Under my direction she was going to Hospital with a friend driving her just to make sure everything was ok.
61 year old patient who was inadvertently given the Fluzone HD with no reported adverse event; Initial information received on 20-Jan-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 61 years old and unknown gender patient who experienced 61 year old patient who was inadvertently given the fluzone hd with no reported adverse event while receiving vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].   The patient's past 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 USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE  (lot number, strength and expiry date was unknown) via unknown route in unknown administration site for Prophylactic vaccination.  On an unknown date the patient developed a non-serious 61 year old patient who was inadvertently given the fluzone hd with no reported adverse event (product administered to patient of inappropriate age) (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  Action taken with INFLUENZA VACCINE TRIVALENT (FLUZONE HIGH DOSE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (61 year old patient who was inadvertently given the Fluzone HD with no reported adverse event).  At time of reporting, the outcome was Unknown for the event 61 year old patient who was inadvertently given the fluzone hd with no reported adverse 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.
Pt. reported by mother to have had a focal seizure, (R) side of face, 1 hour after receiving Tdap shot. Reported that pt had another focal seizure approx. 24 hrs later. (R) side of face with twitching and drooping with second seizure. Fully recovered without further seizure activity since.  Mom spoke with pt's Neurologist who suggested to her that seizure activity could have been triggered by vaccine.
Maybe 8-10 days in I started getting a rash on my left arm close to where the injection was. There were red bumps, they were pretty decent in size. It looked like when you have acne. They were red and itchy. After a while they spread up to my shoulders, across my upper chest then to my other shoulder and down my other arm. It wasn't a lot but they were every few inches of skin. There were maybe 15-20 of them. Now they are creeping down my back. When I go to sleep at night, I would scratch them and they would bleed. I have one on my left collar bone that was bigger than the others. I thought it looked like skin cancer. I went in to my dermatologist. She did confirm it was pre cancerous and she burned it. She told me that if they kept getting scaly and dry then treat it with the chemo cream, 5-fluorouracil.
I had nausea and a headache. I had to go on a bland diet for 6 months. I normally experience this but it was an increase in those symptoms. I went to a gastroenterologist who determined that I suffered from Celiac disease. I had to eliminate gluten from my diet completely. I was advised that it would take up to a year for my body to heal. I had some symptoms prior to the vaccine but they are elevated after the fact.
Pt c/o's scratchy throat & itchy - BENADRYL 25mg then hives over eyes EPIPEN Jr - relieved for 20min rash started again EPIPEN Jr & 30mg ORAPRED given.
8hrs after shot myalgias, decreased energy, rigors, dark urine, headache/pressure. Elevated blood sugar to 300 with known Type I DM. Duration of symptoms - waned over 72hrs.
Information has been received from a nurse concerning a 5 year old female with no history of allergies (including neomycin or gelatin) who on 29-APR-2008 was vaccinated with the second dose of VARIVAX (Oka/Merck) (lot #660283/1971U). The nurse states the patient received 0.1 ml varicella virus vaccine live intradermally in error. The nurse intended to administer an intradermal tuberculin test and made an administration error. The patient was given the intradermal injection in the left inner aspect of the forearm. Within 1/2 hour the are formed an intradermal bleb and was reddened. No other symptoms. Subsequently, the patient recovered. Follow up information was from the registered nurse reported that on 29-APR-2008 the patient was erroneously administered VARIVAX (Oka/Merck) was thought to be PPD that was also drawn up for administration). The patient was examined by the physician immediately post the error. Bleb was noted at surrounding red flat blotchiness. After 40minutes later, local reaction was noted, 3.5 times 2.5 cm surrounding redness, 1 times 1.5 cm central mild swelling, no other symptoms. On 30-APR-2008 the patient's mom reported that area looked fine, no redness (area seemed almost resolved). On 01-MAY-2008 the patient was examined again as redness returned to area. Local erythema and undulation was observed in the mild ventral aspect of right forearm, 20 times 15 mm undulation and 30 times 20 mm erythema. On 02-MAY-2008 the patient's mom reported the area was less red, no other symptoms, the patient recovered. Additional information is not expected.
Vaccine administered to a Pediatric Patient; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to a Pediatric Patient) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 039B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to a Pediatric Patient). On 18-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to a Pediatric Patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details were provided. No treatment medication details were provided.    Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Followup received includes reporter details, Patient details and second dose details were updated.
Scratchiness, itchiness at back of throat - within 30 minutes of receiving vaccine, resolved by that evening Hives on right side of face and neck- within 30 minutes of receiving vaccine, resolved within 2 days  Benadryl 50 mg taken once I was home from work.
Pt reported to pharmacy around 3pm on 9/24, 24hours after receiving Fluvirin influenza vaccine. Pt had hive-like rash widespread on upper torso and arms. Advised pt to begin oral diphenhydramine 50mg, if no improvement or worsening of symptoms or difficulty breathing follow up with Emergency Room or primary care provider.
Swollen arm; Warm to touch; Sore to touch; Burning; itchy; Red; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen arm), FEELING HOT (Warm to touch), PAIN IN EXTREMITY (Sore to touch), BURNING SENSATION (Burning) and PRURITUS (itchy) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Swollen arm), FEELING HOT (Warm to touch), PAIN IN EXTREMITY (Sore to touch), BURNING SENSATION (Burning), PRURITUS (itchy) and ERYTHEMA (Red). At the time of the report, PERIPHERAL SWELLING (Swollen arm), FEELING HOT (Warm to touch), PAIN IN EXTREMITY (Sore to touch), BURNING SENSATION (Burning), PRURITUS (itchy) and ERYTHEMA (Red) outcome was unknown.            No concomitant medications were reported. No treatment related information has been reported.   Reporter did not allow further contact
Low grade fever started the evening of 11/12/2015, noticed swelling, redness and lump at sight of injection in the morning of 11/13/2015, fever peaked around 4:30 am on 11/14/2015, at 8:30 am he had a seizure, paramedics called and evaluated at hospital febrile seizure confirmed.
hives to L lower arm Tx: vitals monitored, Kept for extended pd. 1/26 Allergy eval: Receive 2ND dose in closely monitored area adjacent to ED, Xyzal adverse reaction was allergic  Dose 2 received 2/4 > No adverse reaction
6/24/04 c/o dizzy 10:10AM. 11:25AM dizziness and tingling sensation left arm and fingers. 11:30AM left hand cold and clammy. Monitor vital signs BP tray Resp asset by MD at ER.
Mother noted on 10/8/08 swollen bilateral groin area esp. (R) groin - (R) groin area swollen mother states "larger than a pea" and discolored purple with tenderness. (L) groin also swollen and tender but not discolored. Neck lymph nodes swollen noted 10/9 PM temperature 10/9 102 Po. called mom 10/10/08 AM Nodes not as swollen or tender temp decreased to 99 degrees.
Herpes Zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 67-year-old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On an unknown date in 2016, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration not specified) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient experienced herpes zoster, for which was treated by a healthcare provider. The outcome of herpes zoster was unknown. The reporter considered herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).     Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a 50 year old female patient with none pertinent medical history, drug reactions or allergies. In January 2015 (exact date unspecified) the patient completed a five day dose of acyclovir at an unspecified dose. On 03-FEB-2015 the patient was vaccinated with a first dose of ZOSTAVAX (0.65 ml, subcutaneous, lot# reported as: K018175 with expiry date: 10-JAN-2016). Concomitant therapies included trazodone hydrochloride, hydrochlorothiazide, triamterene and escitalopram. On 05-FEB-2015 the patient experienced a large, swollen, red area with blisters at the injection site. The patient was instructed by the pharmacist to take BENADRYL and an ibuprofen and to apply a cool compress to the injection site. None lab diagnostics studies were performed. The patient sought medical attention via calling the pharmacist.  The outcome of a large, swollen, red area with blisters at the injection site was reported as not recovered. The relatedness between the events and ZOSTAVAX was not reported.
Information has been received concerning a 64 year old female consumer who in October 2010, was vaccinated with a dose of ZOSTAVAX (Merck) (site, dose and lot # not provided). It was reported that 2 weeks after receiving the ZOSTAVAX (Merck), the consumer developed shingles. She underwent antiviral therapy for the shingles episode and no specific drug names, doses and frequencies were given. The consumer stated that the episode of shingles was mild in nature. She had also recently developed some styes around her eyes and was not sure if this had anything to do with ZOSTAVAX (Merck). The consumer was planning to see an ophthalmologist in regards to the styes but had not seen them as of today's call. At the time of the report, the patient's outcome was unknown. The patient sought medical attention. At the time of the report, the patient's outcome was unknown. Follow up information of has been received from a physician refers to a 64 years old female patient. The patient was vaccinated with ZOSTAVAX (lot number 06962) subcutaneously on 07-SEP-2010(in October 2010 as previously reported). Concomitant medications included TRILEPTAL. On 15-SEP-2010 the patient experienced ocular shingles and was seen in system headache pain, left eye and lid swelling. Perhaps blister note left forehead. STATICIN and FLUMADINE (5 mg, oral, qd*7d, from 15-SEP-2010 to 23-SEP-2010, antivirus) were given as treatment for the events. The patient saw ophthalmologist as well. The outcome was reported as recovered/resolved on 1-OCT-2010. Additional information is not expected.
(L) arm/(L) shoulder pain after flu shot. Within a week of receiving flu shot noticed significant pain in (L) shoulder. Basic movements that involve lifting arm above head cause significant pain - removing clothes, toweling off, and sometimes when washes hair. Can't sleep on (L) side - shoulder hurts too much. If rolls onto (L) side hand becomes tingling and numb. Took Rx ALEVE and over the counter MOTRIN - helps but pain persists. Did ice and heat application. Pain specific to spot about 1/2" below shoulder joint.
3-4 days - Extreme fatigue, nausea, fever, couldn't eat, slept day and night On-going 6-7 months - fatigue, muscle, joint, connective tissue pain, unable to lift even blanket so slept on couch, loss of strength Still - fatigue unpredictable resulting in being on the couch and sleeping during the day, continued muscle, joint, connective tissue pain although less than above, loss of strength is on-going but less than above.
Patient reported to IMMZ  department on 1/3/22 at around 9am regarding concern for reaction to 2nd dose of Moderna vaccine received 12/30/21. Patient states they did not feel s/s 15 mins after administration and went home fine. Sometime after, patient stated she started feeling "sick" and "nauseous", "something is not right", which prompted her to present to the hospital 1/1/22. Upon her presentation today, patient noted to have a localized swelling and redness noted on L arm (6x8cm), noted to be below the usual site for injection on the medial part of deltoid. Patient c/o mild nausea, denies CP, SOB, or any other acute s/s. Patient was then seen by the doctor as a walk in, with a differential diagnosis of local reaction vs early cellulitis. Per MD, patient was prescribed a diclofenac gel to use along  with the advice to use ice packs and tylenol to manage pain and swelling on L arm injection site.  ER precautions given by provider if symptoms acutely worsen. If rash persists, patient to return to clinic to reassess need for abx. Patient verbalized understanding.
after administration of both vaccines patient turned her head towards the left side and blacked out for a few seconds and came back this happened 2 times before I administered the epipen to avoid a anaphylactic reaction we called the ems and they checked all her vitals were normal  she refused to go to the hospital and after having a banana and drinking a bottle of water we advised her not to drive  so the patients sister picked her up we followed up with her the next day and she said she was slightly weak because of the shots but other than that she was doing fine
Got Shingles shot on 11/11/2020. Severe pain at injection site in arm. Developed chills and runny nose overnight.
she had given a patient a double dose of polio vaccine with giving IPOL and Quadracel, no AE; Initial information received on 18-Dec-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 5 years old male patient who received received vaccines DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot number and expiry date: not reported) not reported via unknown route in unknown administration site, on an unknown date and IPV (VERO) [IPOL] (lot P1A43 and expiry date: not reported) via intramuscular route in the right deltoid, on 17-Dec-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included INFLUENZA VACCINE INACT SPLIT VIRION 4V (FLUZONE QUADRIVALENT) for Immunisation; and MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) for Immunisation.  It was a case of actual medication error due to extra dose administered. It was reported that patient a double dose of polio vaccine with giving IPOL and Quadracel on the same visit  At the time of reporting, no adverse event was reported.  Information on batch number requested for QUADRACEL.  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.
This spontaneous report as received from an other health professional refers to unknown number of patients of unknown age. The patients were vaccinated with RECOMBIVAX HB 0.5ml which was stored as low as 24F on multiple occasions. No treatment information was reported. This is one of several reports received from the same source. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. All telephone attempts to obtain follow-up information have been unsuccessful.
Shaking, nausea, body aches, great fatigue, uncontrollable crying.
About 10 minutes after getting the shot, while waiting in the Doctor's waiting room, I began to feel dizzy and began sweating.  They moved me into an exam room, and which time I passed out.  I was awoken by the doctor standing over me, rubbing my chest.  I was subsequently transferred to the ER.
A lot of pain in lower back (left side). Three days later broke out in a rash.
Patient was given tdap immunization and experienced heat, redness, and edema as well as small superficial bumps at injection site x4-5 days. Patient used warm packs for comfort and eventually reaction spontaneously resolved. We had a patient experience similar reaction (this time requiring antibiotic therapy) this past week as well which I will report in separate event.
Within ten minutes of receiving the shot, I felt a sensation travel up my arm, shoulder and neck until it stopped in my right jaw area, and felt like novocaine kicking in. I have since had roving tingling, numb-ish sensation, and pain on both sides of my face and throughout my mouth, tingling in my legs, severe muscle tension in my neck, chills and fever, and dizziness. I have seen several doctors but no one has been of any help. I am trying alternative therapies and have have some improvement of symptoms.
"High pitched crying secondary to DTP ?; Crying lasted approx 1 wk";
Lots of swelling, pressure, redness and itching at the injection site started about 12 hours after injection. Looks like a large spider bite. Iced it but still experiencing the same symptoms. Low grade fever, vertigo, chills, fatigue - all set in about 12 hours after the injection and lasted 36 hours, vertigo is still happening.