chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had the new shingles shot/ had shingles/suspected vaccination failure; Sine Shingles; Nerve pain; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and post herpetic neuralgia. On an unknown date, the outcome of the vaccination failure, shingles and post herpetic neuralgia were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 08-AUG-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient stated that, not always, he/she had since shingles. The patient had no rash because he/she had the new shingles shot. The patient further stated that, you might get the nerve pain but if caught quickly enough and not the rash. The patient still did 10 days on stereos (unspecified) to knock down the virus. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Approximately 9 days after injection, a circular red and slightly itchy rash appeared at the injection site.
As soon as I started to inject vaccine into arm patient arm started to swell and get a welt at injection sight. I finished injecting vaccine but by the time I finished the welt was about 1.5 inches in diameter and about a 1/4 inch thick. Notified provider and he looked at it and stated it was a local reaction and stated to patient to watch it and put ice on it when he got home. He also told patient if he had any other side effects to come in to clinic or go to ER.
This report is regarding the Pfizer COVID-19 vaccination you received on the above date, which was lot number FD0809. The Department of Health, Centers for Disease Control and Prevention (CDC), and Pfizer have determined that the dose of vaccine that you received is valid.
Information ahs been received from a doctor of pharmacy concerning a 29 year old female with no prior medical history, no known drug allergies, and a latex allergy who in approximately August 2002, was vaccinated with a dose of rubella virus vaccine live (second generation) (lot #641025/0279M). Concomitant therapy included cefazolin sodium (ANCEF), famotidine (PEPCID), acetaminphen/oxycodone hydrochloride (PERCOCET) and ibuprofen. At the time of vaccination, the patient was hospitalized following the delivery of her child and had an "immediate classic anaphylactic reaction" post vaccination. Treatment included epinephrine, methylprednisolone sodium succinate (SOLU-MEDROL), and diphenhydramine hydrochloride (BENADRYL). The reported questioned whether "the patient's latex allergy may have been the cause."
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No concurrent conditions, medical history or allergy/drug reactions were reported. On 03-MAY-2017, the patient was vaccinated with ZOSTAVAX vial 19400 PFU (plaque-forming units), lot# M041086, expiry date: 03-JAN-2018 (dosing details, route unknown) instead of VARIVAX, for prophylaxis. ZOSTAVAX was reconstituted with sterile diluent(MERCK STERILE DILUENT) lot# N007932, expiry date: 06-MAY-2018 (dosing details, route unknown).  No adverse effects were reported. There were no product quality complaints (PQC) involved. Additional information has been requested.
8.5cmx7 cm red, tender, warm induration at right deltoid. Began after injection of DTAp Developing cellulitis. Patinet placed on Keflex x 7 days.
Left shoulder pain and decreased range of motion started 2 days post flu vaccination and has persisted (vaccine injection LUE). Using ibuprofen with effect. To follow-up with PCP for further eval.
Sore in the shoulder; This spontaneous case was reported by an other and describes the occurrence of ARTHRALGIA (Sore in the shoulder) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Hospitalization on 29-Mar-2021, Dehydration (Patient hospitalized, outcome unknown), Sores mouth (Patient hospitalized, outcome unknown), Sinus infection (Patient hospitalized, outcome unknown), Dry mouth (Patient hospitalized, outcome unknown) and Dysphagia (Patient hospitalized, outcome unknown). Previously administered products included for an unreported indication: LENVIMA (8 mg daily dose taken orally,  Medication on hold.) from 16-Nov-2020 to 29-Mar-2021 and EVEROLIMUS (5 mg taken orally.  Medication status unknown.) until 29-Mar-2021. Concurrent medical conditions included Pinched nerve (Recovering) and Carpal tunnel syndrome (Recovering). Concomitant products included LENVATINIB MESILATE (LENVIMA) from 16-Nov-2020 to an unknown date for Renal cancer.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced ARTHRALGIA (Sore in the shoulder). In March 2021, ARTHRALGIA (Sore in the shoulder) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was taking an unknown antibiotic for an unknown indication and using a mouth rinse for an unknown indication.  Patient was scheduled for a neurological visit for his hands to receive an injection.   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: fallow up received on 20-may-21 contain no new information
Achy feelings, lethargy, some soreness in my right arm around injection site and forearm
achy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achy) in a male patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (achy). At the time of the report, PAIN (achy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided. no concomitant medications are provided.
pt recvd vax & devel fever  of 101 24 hrs after vax; body stiffened up & pt began to scream; high pitched cry for about 7 hrs; would not eat or sleep; would not calm down; tx w/ apap drops;
Information has been received from a physician concerning a 5 year old male who in approximately 2002, "at age 1" was vaccinated with a 0.5mL dose of Varivax. On approximately 25-MAY-2006 the patient broke out with chickenpox. He had approximately 20 lesions. Unspecified medical attention was sought. At the time of this report, the patient was recovering. Additional information has been requested.
hearing loss; This spontaneous report has been received on 02-APR-2020 from a lawyer, regarding a case in litigation and refers to a patient of an unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date in 2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) for the long-term prevention of shingles and/or zoster-related conditions at a hospital. Subsequent to the patient's zoster vaccine live (ZOSTAVAX) inoculation, on an unknown date, the patient was treated by a healthcare provided for hearing loss. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of hearing loss was not reported. The reporter considered the hearing loss to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of hearing loss was considered to be medically significant.
Received Pneumonia booster shot from pharmacy. I accumulated a bacterial infection of my lungs and a spot.
Patient is fully vaccinated. ED visit on 12/24/2021 and COVID positive. Patient presenting with 3 days of body aches, occasional cough, nausea and vomiting, loss of taste and smell. She does live in a house with other sick people.Denies having chest pain or shortness of breath. Decreased appetite. BP 136/69  | Pulse 78  | Temp 98.4 °F (36.9 °C)  | Resp 19  | Ht 154.9 cm (5' 1")  | Wt 77.1 kg (170 lb)  | SpO2 100%  | BMI 32.12 kg/m² Given IV fluids, Zofran, Pepcid. Discharged.
Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination. Wants new booster instead of revax
Pulmonary Embolism and Lung Infarction.  Signs began 5/1, to E.R. 5/3. Obviously, doctors unsure if from vaccine.
The patient passed out in her chair while being observed in front of the pharmacy about 5 minutes after receiving the Covid vaccine.  She was laid down from her chair and became fully responsive about 10 seconds after being laid down. 911 was called and the pt was checked by EMTs and escorted to her car with the patient's mother
Severe headache for 5 days.  Headache continues to this time only less severe and getting better.  Slight fever for one day after vaccination - 100.2.
herpes zoster outbreaks; vision issues; tinnitus; Information has been received from a male patient of unknown age and a lawyer referring to himself. The patient's medical history, concurrent condition and concomitant therapy were not reported.  On or about 16-APR-2016, the patient was vaccinated with Zoster Vaccine Live (ZOSTAVAX) (strength, dose, frequency, route, lot# and expiration date were unknown) for routine health maintenance and the prevention of shingles (herpes zoster).  On an unknown date, the patient experienced with recurrent herpes zoster outbreaks, vision issues and tinnitus. The patient did not recover from all the events.   The reporter considered the events were disability.  The reporter considered the events were related to Zoster Vaccine Live (ZOSTAVAX).
1/22/2022 a Moderna dose was administered by mistake to a patient with a JANSSEN vaccine and a Moderna booster previously administered on November 24, 2021. He was monitored for 1 hour and there was no reaction.
No other issues or concerns noted a time of call; Patient administered expired PNEUMOVAX 23; This spontaneous report was received from a registered nurse and refers to a 75 year old patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 19-OCT-2021, the patient was vaccinated with expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # S028602, expiration date 28-JUN-2021 for prophylaxis (exact dose, anatomical location and route of administration were not reported). No other issues or concerns noted a time of call.
Extremely heavy bleeding during menstrual cycles, consistent  headaches (didn?t not have prior)
No adverse effect; Improperly stored; This spontaneous report was received from a medical assistant referring to a patient of an unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/ allergies and concomitant medications were not reported. On 12-NOV-2019, the patient was vaccinated with second dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength, formulation, dose/frequency, route were unknown) for prophylaxis (product storage error). Reporter stated that, one of the 2 lots listed were administered but unable to differentiate which one at time of call Lot# R033251 expiry date: 29-JUN-2020, Lot# S001101 expiry date: 21-OCT-2020. The vaccine was stored at a temperature of 1.8 degree Celsius for 3 minutes. There was previous temperature excursion of 14.2 degree Celsius for 2 hours 58 minutes. The call was because of data logger. No adverse effects were reported. The outcome of product storage error and no adverse event was unknown.
Red, itchy, painful hives erupted all over my body body starting a day after getting the second Hep B shot. This lasted for at least a month. I was put on a steroid regiment by my primary doctor which did not cure the hives. I had to go to clinic and see a doctor and be put on another 14-week regiment of steroids which helped clear out the allergic reaction, although it took at least a few months to entirely clear out.
Received Tdap 3-4-16. Felt a "knot" at site of inj. 3-5-16 Noticed redness, pain. 3-6-16 more red and more painful. Iced the site. 3-7-16 area 8x8 cm redness 4 mm induration still painful warm to touch.
Site of inoculation was sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Site of inoculation was sore) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (Patient mentioned that she has given birth vaginally 8 times with no real problems and she had zero miscarriages. She stated that she has 8 healthy children.). Concurrent medical conditions included Drug allergy (Bad reaction Trazodone), High cholesterol since 2005 and Prediabetes since 2010. Concomitant products included ATORVASTATIN for High cholesterol.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021 at 4:00 PM, the patient experienced VACCINATION SITE PAIN (Site of inoculation was sore). At the time of the report, VACCINATION SITE PAIN (Site of inoculation was sore) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.   This case was linked to MOD-2021-067642 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Jun-2021: Follow up received on 06 JUNE 2021 and does not any new information.
imovax series was started and prescribed from the emergency room as a 4-dose series and not the on-label 5-dose series for post exposure with no reported adverse event; imovax series was started and prescribed from the emergency room as a 4-dose series and not the on-label 5-dose series for post exposure with no reported adverse event; Initial information received on 06-Dec-2022 regarding an unsolicited valid non-serious case from a other health professional.  This case involves an unknown age male patient who reported that rabies (HDC) vaccine [IMOVAX RABBIA] series was started and prescribed from the emergency room as a 4-dose series and not the on-label 5-dose series for post exposure with no reported adverse event.   The patient's past medical history included Animal bite (bit by a dog) on 05-Dec-2022. The patient's past medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect rabies (HDC) vaccine, Powder and solvent for suspension for injection (strength, frequency, lot number, and expiry date: not reported) via unknown route in unknown administration site for bit by dog (Animal bite).  On an unknown date the patient had imovax series was started and prescribed from the emergency room as a 4-dose series and not the on-label 5-dose series for post exposure with no reported adverse event (product prescribing error) (Inappropriate schedule of product administration) (latency: one day).   It was reported"The caller reported that the consumer was bit by a dog, on 05Dec2022; that the IMOVAX series was started and prescribed from the emergency room as a 4-dose series and not the on-label 5-dose series for post exposure; that the consumer will miss the 19Dec2022 dose due to being out of town, but can make the dose up on 21Dec2022".  Action taken was not applicable.  The outcome was Unknown.   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 guidelines. 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.
6:00pm- intense shaking chills lasting 5-6 hrs 7:00pm- body pain, moderate- felt like nerve endings all over my body were on fire- applied topical CBD lotion (maybe 200mg?) 8:30pm- pain at injection site, mild to moderate (ongoing, 12+ hr) 11:00pm- mild fever (100-101F), spiked to 101.7F at 3am but effectively controlled by Tylenol  All symptoms mitigated with 1200mg Tylenol per 8 hrs (took 600mg at 11am after vaccination, 1200mg 7pm, 1200mg 3am); chills were barely controllable but fever and body aches showed marked improvement. Pedialyte and topical CBD may also have lessened body aches.
Rashes (allergy-like) came out from the patient's skin on tummy, right and leg thighs and legs and arms on the night of his vaccination day. Small visible marks appeared on his face. The doctor (who also administered the first booster shot of HiB), gave him Alnix (Cetirizine diHCL) drops 1.2 mL every 12 hours and Aerius syrup (Desloratadine) 2.5mL once a day, preferably lunch time. It was administered 3 days after the suspected adverse effect appeared. Until today, for 12 days of medication, allergy rashes are still appearing. The rashes will subside then appear again.
Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 20-Apr-2022; Patient received an expired vaccine on 28-Feb-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine on 28-Feb-2022) and PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 20-Apr-2022) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 084J21A) for COVID-19 vaccination.  Previously administered products included for Product used for unknown indication: Janssen (Batch no: 1808609.) on 25-Mar-2021. Past adverse reactions to the above products included No adverse event with Janssen.   On 28-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine on 28-Feb-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 20-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine on 28-Feb-2022) and PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 20-Apr-2022) outcome was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  No Concomitant product use was reported.  The reporter stated that they initially called on 12-May-2022 and reported a total of 18 patients received expired doses after the 30 days Use by Date. On 17-May-2022, the reporter reported after doing further research, that the actual total number of patients that received expired doses after the 30 days use by date was 82 patients total and not 18 patients. The date the vial initially stored in the refrigerator was 11-Jan-2022 which means that all doses administered more than 30 days after 11-Jan-2022 were not in accordance with the university. Reportedly, the vial did not undergo any temperature excursions.  The patient had not reported adverse reaction to the reporter's knowledge.  No treatment information was provided.
This spontaneous report was received from a 64 year old male patient referring to himself. The patient's has not drug reactions/allergies. The patient's concurrent conditions included tooth ache. On 19-DEC-2017, the patient was vaccinated with a dose of PNEUMOVAX 23, 1 vaccine dose, to prevent pneumonia (route of administration, lot # and expiration date were not reported). Concomitant therapies included amoxicillin. On 20-DEC-2017, the patient experienced a low grade fever, sore joints (arthralgia), and pain at the injection site. The patient also felt "run down" (feeling abnormal). No laboratory diagnostic tests were performed and no treatment was received for the events. At the time of reporting, the outcome of the events was reported as not recovered. The causality assessment between the events and PNEUMOVAX 23 was not provided.
This spontaneous report was received from a physician, via company representative, and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On 28-SEP-2015, the patient was vaccinated with an improperly stored PNEUMOVAX 23 10 PK, lot # L002310, expiration date 08-JUL-2016, at a dose of 0.5 ml (route and anatomical location of administration were unspecified). The vaccine underwent a total temperature excursion, of 816 hours. The lowest recorded temperature was 27 Fahrenheit degrees (-2.777777778 Celsius). The vaccine status was reported as "in excursion'. The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effects were reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
back pain and body aches Narrative:  employee states: starting around 6pm the evening of the injection she experienced extreme lower back pain and body aches the next evening symptoms resolved around 5pm
below injection sight 6x6 redness, throbbing, painful to touch, fatigue, stomach issues, body aches
Patient experienced feeling faint, blurred/blacked out peripheral vision, dizziness, sweats, loss of typical skin color a few minutes after receiving a flu vaccine. Patient recovered within 30 minutes after sitting down, eating, drinking water, placing a cold towel on forehead. He had not eaten the morning before receiving the vaccine and was nervous about the needle and receiving a flu shot. Explained that nerves along with not eating can cause changes in blood pressure and blood sugar that could cause his symptoms. He felt fully recovered and back to normal within 30 minutes.
Severe fatigue, brain fog, nerve pain, muscle weakness, chest pain, balance difficulty, shortness of breath, elevated blood pressure.
Pain after flu shot was given. Per patient she had MRI which showed direct impact trauma due to flu shot given too high. Per patient Dr. diagnosed with mild tendonitis and infraspinatus.