chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rashes came out the whole body within the next day after the second dose of vaccine.; This is a spontaneous report from a contactable consumer (patient).A 60-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EW0164) via an unspecified route of administration, administered in left arm on 24Apr2021 at 13:15 (at the age of 60-year-old) as dose 2, single for COVID-19 immunization. The patient had no medical history. Concomitant medications were not reported.  There were no known allergies. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: not reported) via an unspecified route of administration on an unspecified date (at the age of 60-year-old) as dose 1, single, for COVID-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no List of any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 25Apr2021 at 12:00, within the next day after the second dose of vaccine the patient experienced rashes came out the whole body.  The event resulted in doctor or other healthcare professional office/clinic visit. The patient was not received any treatment of event. Outcome of the event was not resolved.  Follow-up attempts completed. No further information expected.
Fever and terrible chills about 12 hours after receiving the shot. Lasted about an hour. Woke up the next morning with mild fever, headache, aches, injection site very painful. Started taking Tylenol.
Information has been received from a lawyer and a consumer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medications were not provided. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX (lot # and route not provided) to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 03-MAY-2010, a healthcare provider administered the ZOSTAVAX vaccine to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. On or about 19-OCT-2016, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX vaccine, and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive 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; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
Patient has not received their 2nd dose Patient is at day 53; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient has not received their 2nd dose Patient is at day 53) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient has not received their 2nd dose Patient is at day 53). On 05-Apr-2021, PRODUCT DOSE OMISSION ISSUE (Patient has not received their 2nd dose Patient is at day 53) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product information was not provided. Treatment information was not provided.
10/9/08 onset facial swelling and numbness affecting jaw, parotid, and cheek area.  Seen by Urgent Care phys and referred to EENT. Tx w/ antibx and prednisone w/o results. CT scan neg. Swelling and numbness persist.
Pt had loss of consciousness while receiving the vaccine.  Very pale & diaphoretic. Taken to Observation are.  BP 82/56 P48 3:55PM BP 102/64 P 71  Sitting up drinking juice. 4:15PM Feeling better. Left w/o assisstance with mother & brother.
shot does hurt after; This case was reported by a consumer via interactive digital media and described the occurrence of pain 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 pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 24-Apr-2022 Reporter's comments: This case was received from media page. This case was reported by the patient. The patient received Shingles vaccine and shot hurt after. But from what the patient hear it would be worth it.
Swelling of face including eyelids 2 days following vaccination. Treatment is prednisone 5mg daily for 7 days. Outcome pending.
Vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient did not experience any adverse event.  No concomitant medications were reported.  No treatment information was reported.   This case was linked to MOD-2021-395985 (Patient Link).
Started feeling confused, numbness to right cheek bone area, trouble talking, had headache prior most of day, mild.
On 3/1/16, pt noticed redness and pain of the entire left deltoid area w/ severe pain.
Patient reports that he developed shoulder pain, lower back pain, feeling of cold and chills last night at about 1900. He states that he feels a little warm, but has not checked his temperature. He denies any additional symptoms, including runny nose. He has not taken anything for it. Informed him that this can be common side effects from vaccines that he received, including the muscle pain, soreness and not feeling well; informed him that the symptoms can also include tiredness, headache, shivering, fever, stomach pain and nausea and these symptoms usually go away on their own in 2 to 3 days. Advised him to take OTC tylenol or motrin, push fluids and rest.
Felt dizzy at 2:01 PM taken to medical observation BP 126/78 Oxygen saturation 100% 2:30 PM BP 127/75 sitting BP 119/79 standing, fluids encouraged, reclining on stretcher.  Reports feeling better but "very tired now".  Instructed to call for ride home since she drove herself in. 2:48 PM BP 121/81 HR 77 standing 2:57 PM patient discharged via wheelchair to husband's car
This spontaneous report as received from an other health professional refers to patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ lot # M042821 for prophylaxis. No adverse effects were reported. Data logger was involved. This is one of several reports received from the same reporter. Additional information is not expected.; Sender's Comments: US-009507513-1708USA005822: US-009507513-1708USA005843:
pt recv vax 13JUL95 & 2 days p/vax pt devel a local rxn @ the site of vax described as inflamed hot, hard & painful;pt did not devel a fever;MD suspected cellulitis & pt was started on Duracef;pt has n hx of prev pneumococcal immun;
10-11 days after my first dose, I developed a large red spot on my arm where the injection site was. It was red, hot, hard, and itchy, with a well defined border. The redness and hardness has gone down. It is still itchy and hot with a well defined border.
Inflammation of tongue and sensitive mouth to spicy/acidic foods on Sept 16.   Inflammation continued on Sept 17 with addition of sores/ulcers on tongue, inside of mouth.   Sores and Inflammation still present on Sept 18th.
Entire left side numb/ stomach or intestines felt like they were on fire. Rash from chest to neck.
No adverse event; vaccines administered past the expiration date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccines administered past the expiration date.) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 037A22B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Nov-2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 15-Nov-2022,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccines administered past the expiration date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccines administered past the expiration date.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (vaccines administered past the expiration date.).    No concomitant medication was reported. It was reported that the vaccines were stored in a standard freezer (15°C to -25°C). Their temperatures were Max -24C and Min -23C The following doses/Lot numbers were impacted. Trade Name Moderna Bivalent Lot AS7140C Received 9/2/2022 CDC Expiration 5/7/2023 Report Type EXP Date of Administration 5/8/2023 doses 1 Trade Name: Moderna COVID-19 Vaccine Lot: 037A22B Received: 5/19/2022 CDC expiration 10/31/2022 report type EXP Date of administration 11/15/2022 doses: 1 Moderna COVID-19 Vaccine Lot 060H21A received: 12/27/2020 CDC expiration: 3/28/2022 report type: EXP 4/11/2022 doses: 13 Moderna COVID-19 Vaccine Lot: 083B22A received: 11/15/2022 CDC expiration: 2/28/2023 report type: EXP administration date:4/5/2023 doses: 3. HCP doesn´t have any patient identifiers. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2023: Live Follow up received contains No NewInformation
This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 08-APR-2015, the patient was vaccinated with improperly stored PNEUMOVAX (lot # K024976 exp date 09-JUN-2016) (dose and route not reported). The temperature and time of excursion was 1.11 C for 64 hours. The vaccine status was reported as "in excursion", the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Swelling, hard tissue 3cm cir. Warm compress to area, TYLENOL for pain/fever (should it develop).
Patients mother called nurse at 11:00 am 2/9/04. Nurse returned call at 11:30 am. Mother stated son's arm starting swelling Saturday night 2/7/04 stated son complained of pain to right arm was taken to medical center on 2/8/04 at 11 pm. States ER doctor said patient had cellulitis and an infected lymph node on right side of neck was given prescription for Keflex and sent home with parents.
Pain on left arm for 1 day,  Headaches 6 days, bodyache 6 days ,chills ,soft stool for 2 days and Tiredness 6 days.
Droopy right eye, numbness/tingling of right arm and fingers, slight headache, heaviness feeling on right side of face, swollen right foot.
Fever of 103.9, extremity shaking (?seizure), 911 activated, sent to E.R. After discharge from E.R., pt. came into doctor's office, and admitted to Pediatrics unit for seizure work up.
Patient reported a "tingling sensation" to his face 10 minutes post vaccine.  Swelling under eyes  were also noted.  At 1410 patient reported symptoms subsided. By 1440 patient requested that he leave and another individual to drive was confirmed. Importance of following with PCP was enforced.
Fainting; vomiting; Other vaccine same date product: Flu vaccine; Other vaccine same date product: Flu vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Nov2022 at 10:30 as dose 1, single (Batch/Lot number: unknown) at the age of 53 years, in left arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 04Nov2022 as dose 1, single (Batch/Lot number: unknown), in right arm for immunisation. The patient's relevant medical history included: "Bipolar" (unspecified if ongoing); "Known allergies: Yes (penicillin)" (unspecified if ongoing); "Known allergies: other antibiotics" (unspecified if ongoing). Patient did not have COVID-19 prior to vaccination and was not tested post vaccination. There were no concomitant medications. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 04Nov2022, outcome "unknown" and all described as "Other vaccine same date product: Flu vaccine"; SYNCOPE (medically significant) with onset 04Nov2022 at 18:45, outcome "recovered", described as "Fainting"; VOMITING (non-serious) with onset 04Nov2022 at 18:45, outcome "recovered". The events "fainting" and "vomiting" required emergency room visit. Therapeutic measures were not taken as a result of syncope, vomiting.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Administered only the diluent; Administered only the diluent; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number 5NC4N, expiry date 8th October 2023) for prophylaxis.   On 30th January 2023, the patient received the 1st dose of Shingrix. On 30th January 2023, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 20-FEB-2023 Reporter's comment: The HCP(health care professional) reported that patient received dose of Shingrix in the series was administered with diluent only.  No side effects was reported.  The reporter consent to follow up. Additional Supportive Information: The patients received Shingrix vaccines with diluent only which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
This case was upgraded to serious on 13 March 2015 due to new serious events reported. Initial report received from consumer (the patient) on 18 August 2014. A 62-year-old female patient, whose medical history and concomitant medications were not reported, had received a third dose of IMOVAX (batch number were not reported) intramuscularly in right arm on 05 August 2014. It was reported that an unspecified date the patient received Immunoglobulin for rabies (unknown which product). 06 August 2014 the patient experienced fatigue and muscle pain at injection site in right arm with pain shooting in neck and back. Also had experienced some soreness in left arm. The patient had required ER/doctor visit. The corrective treatments and laboratory investigations were not reported. At the time of this report the outcome of event was unknown. Follow-up information was received for this unsolicited case on 13 March 2015 from a consumer, which upgraded the case to serious. The patient received Rabies vaccine, a "series of 5 shots in arms (same reaction) and two in upper thighs (immunoglobulin)" and experienced increased pain, soreness and lameness. The patient reported that since the vaccine her health has been poor with increased inflammation, increased autoimmune reaction and hypersensitivity to everything (chemicals, food, touch, exercise etc). The date of vaccination on 05 August 2014 was reported as "1st (two out of five)". Pre-existing medical conditions were reported as chemical sensitivities, autoimmune Hashimoto, fibromyalgia, chronic post-Lyme disease, allergy to dyes and preservatives, aluminum, formaldehyde and mercury. The patient was vaccinated at a public health clinic/hospital. It was reported that rabies immunoglobulin was given the same day as "1st two rabies vaccine." It took almost one month to recover from the pain. Since the incident, the patient reported that her immune system has been compromised with increased sympathetic overdrive causing pain, inflammation, chemical sensitivity, skin disorders etc, for the past six months. The patient believed that she was given a standard size needle verses a smaller one and that may have impacted pain. The patient reported that she is thin with very little upper arm fat and should have been given a pediatric needle. The patient's biggest concern is that since she already had an autoimmune disease she believes her central nervous system was disrupted and over stimulated. She experienced a severe sympathetic overdrive and increased sensitivity for six months since the vaccine. She has been housebound for months due to a weakened immune system, increased skin inflammation, increased allergies, increased muscle weakness and increased reactions to common allergies and chemicals. The patient recovered on an unreported date. Documents held by sender: none.
Dx loss of taste  ? loss of smell ? Nasal Congestion GRAVIDE PARA: G 3 P 1 1 0 2 EDD: 08/19/2021
Pt experienced joint pain in her knuckle closer to fingernail ring finger (both) also joint pain left hand same side as injection site pt has osteoarthritis the injection made it worse pt receives cortisone injection every 6 months seem to help until she got the vaccine it usually last 5-6 months.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age. On an unknown date, the patient was vaccinated with ROTATEQ vial, lot # H17671m expiration date 25-MAR-2014 (dose and route were not reported) that was exposed to 12C for 173.5 hours, which was an excursion that was not supported by in-house stability data. No adverse effect reported. No concomitant medications were reported. This is one of several reports received from same source. Additional information has been requested.
Patient reported numbness and tingling  in lips and fingers on right hand at 5 minutes post vaccination. She was taken to the Emergency Room by Employee Health Nurse (walked) where tingling/numbness in lips had resolved upon arrival to ER and was decreasing in hand.  She had full resolution after 1.5 hours. She was observed for 2 hours, no interventions, symptoms resolved,  and then she  returned to work.
Diarrhea  Vomiting  Fainting  Chills  Sweating
little GI distress; nasal congestion; muscle pain; really bad headache; fatigue; chills; body ache; A spontaneous report  was received from a healthcare professional concerning a 67-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events really bad headache, chills, body ache, muscle pain, fatigue, little gi distress, nasal congestion.  The patient's medical history was not provided. Concomitant medications reported were Amlodipine, OTC generic Zyrtec, Vitamin D, Baby Aspirin for drug use for unknown indication.  On 31 Dec 2020, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 026L20A) intramuscularly for prophylaxis of COVID-19 infection and on 29Jan2021,she received second dose of mRNA and has not had any reactions to it yet.  On 11 Jan 2021, the patient experienced the event(s) really bad headache. chills, body ache, muscle pain, fatigue, little gi distress, nasal congestion.  Treatment details included Aspirin.  Action taken with mRNA-1273 in response to the events were not applicable. The outcome of event(s) really bad headache was considered resolved on 16 Jan 2021.The outcome of event(s) chills was considered resolved on 16 Jan 2021.The outcome of event(s) body ache was considered resolved on 16 Jan 2021.The outcome of event(s) muscle pain was considered resolved on 16 Jan 2021.The outcome of event(s) fatigue was considered resolved on 16 Jan 2021.The outcome of event(s) little gi distress was considered resolved on 16 Jan 2021.The outcome of event(s) nasal congestion was considered resolved on 16 Jan 2021 was unknown.
Fatigue after 1st shot; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue after 1st shot) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced FATIGUE (Fatigue after 1st shot). On 23-Apr-2021, FATIGUE (Fatigue after 1st shot) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant and treatment medication was reported.   This case was linked to MOD-2022-473936, MOD-2022-473944 (Patient Link).
Raised rash and hives on chest and back for approximately a month and a half. After second dose same ease occurred on both sides of my head a few days after receiving the injection. Rash broke out on elbows and lower abdomen a few weeks later and broke out on right side of lower abdomen on April 14th.  Treated with Triamcinolone Acetonide Cream.   Rashes responded to treatment so far. Just started treating right side of lower abdomen on 4/14.
Pt recv vax on 3/25/99; on 3/26/99 pt exp red/ hot/ swollen vax site, fever (100.3), chills, weak, ill feeling