chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Right shoulder tendonitis/used arm but difficult Dec 2021; Right shoulder tendonitis/used arm but difficult Dec 2021; The initial case was missing the following minimum criteria: Unspecified product and Unspecified AE. Upon receipt of follow-up information on (01Aug2022), this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A 72-year-old female patient received BNT162b2 (BNT162B2), on 11Nov2021 as dose 3 (booster), single (Lot number: FF8844) at the age of 71 years, in right deltoid for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: coviD-19 biontech (Dose 1, Single, Lot/Batch Number: EL9267), administration date: 10Feb2021, for Covid-19 Immunization, reaction(s): "Covid-19"; coviD-19 biontech (Dose 2, Single, Lot/Batch Number: EN6204), administration date: 03Mar2021, for Covid-19 Immunization, reaction(s): "Covid-19".  The following information was reported: LIMB DISCOMFORT (non-serious), TENDONITIS (non-serious), outcome "recovered" and all described as "Right shoulder tendonitis/used arm but difficult Dec 2021". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of limb discomfort, tendonitis.  Additional Information: I Did Have an MRI Which Showed Some Stenosis L4/L5/S1 Levels. Where I Saw Neurologist in Withheld and In Withheld, Larch Advised Name Withheld Not Currently Candidate of Surgery. So Tried Nerve Lost Black Injections and Found Only Temporary (24 Hrs). Relief. Hip Pain Continues as Well as Burning Sensation- Attributed to Stenosis but Not Experienced Prior To Vaccine Injections. My Belief Is That Vaccinations Contributed to Tendmitis and Neuropathy Symptoms At Least Stirred Things Upto the Point Where I Noticed Changes in How I Walk and Move in General-Hip Pain Is Intermittent but Burning Sensation Is 24/7 For Past 16 Months
PT stated she felt hard lump the evening following her injection.  Pt states she saw swelling and redness along with itching the day after, and subsequently reported to the immunizations clinc. Denies any other symptoms.
Swelling on her left arm; Tingling on the right side of her face; A spontaneous report was received from a health care professional concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced peripheral swelling and paraesthesia.   The patient's medical history included bell's palsy and hemiated disk on patients neck. No relevant concomitant medications were reported.   On Date DD-jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, the patient experienced the events swelling on left arm and tingling on right side of her face.   Laboratory details if provided.   No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date, the outcome of the events swelling on left arm and tingling on right side of her face was unknown.
This spontaneous report was received from a pharmacist via a company representative, concerning a female patient of an unknown age. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were unknown by the reporter. On an unspecified date in 2014 (reported as "sometime in 2014"), the patient was vaccinated with PNEUMOVAX 23 from lot # K004207 with expiration date on 13-MAR-2015 (strength, route of administration, and anatomical location were not reported), one dose was administered for prophylaxis. On an unspecified date after vaccination, the patient began experiencing cellulitis at the injection site as well as swelling and redness at the injection site too; and it lasted approximately four days then resolved (date unspecified). The patient sought medical attention by calling to the pharmacy and was advised to apply ice to the injection site to decrease the redness and swelling but it was unknown if the patient did it. It was unknown if laboratory diagnostics studies were performed. No product quality complaint (PQC) was involved. The causal relationship between the cellulitis, swelling and redness at the injection site with  PNEUMOVAX 23 was not provided. This is one of several reports received from the same source.; Sender's Comments:  US-009507513-1711USA007676: US-009507513-1711USA006166:
Difficulty breathing; chest pain, headache. vital signs at 1148: BP 188/97; pulse 107. Vital signs at 1153: BP 162/99, pulse 99; respiration 22; Blood glucose at 98 milligrams per deciliter.   At 1144 patient give Epinephrine  using epi-pen. At 1145 patient on oxygen at 2L/minute.
dizziness & feeling of just having gotten off a bad roller coaster - head felt scrambled/fragile, dizzy.  lasted 8 days post second vaccine.  (note: Also had dizziness after first vaccine (which began about 54 hours post vaccine and lasted about 24-36 hours).
29 patients received Moderna Covid-19 vaccine after 30 day refrigerator beyond use date; 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 EXPIRED PRODUCT ADMINISTERED (29 patients received Moderna Covid-19 vaccine after 30 day refrigerator beyond use date) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (29 patients received Moderna Covid-19 vaccine after 30 day refrigerator beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (29 patients received Moderna Covid-19 vaccine after 30 day refrigerator beyond use date) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided.
other zoster related injuries; shingles; Information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown gender who at the time of vaccination with zoster vaccine live (ZOSTAVAX) was 82 years old. No information about the pt's medical history, concurrent conditions or concomitant medications was provided. On or about 21-OCT-2013, the pt was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) by a pharmacist at a pharmacy for the long-term prevention of shingles and zoster-related conditions. Subsequently, on unknown dates, the pt was treated by a physician at a family care facility for the following injuries resulting from the pt's zoster vaccine live (ZOSTAVAX) use: shingles and other zoster related injuries. The outcome of the events was not provided. The reporter considered the events of shingles and other zoster related injuries to be related to zoster vaccine live (ZOSTAVAX).
Patient indicates she felt like she had a rapid heart rate. BP 140/79, Pulse 78. No other symptoms. Felt better after 15 minutes.
urticaria rash, erythema w/small welts 25cm in diameter p/5min of inj;no increase in size or other sx 15min p/vax;no erythema or welts 30min p//vax;
On 2nd day post vaccination, pt dvlped 1 1/2 x 3" soft induration; w/ hard center.
Started having a scratchy throat and took a home COVID-19 test and it was negative. Didn't trust the test and went to an urgent care. Tested again and was positive. Prescribed PAXLOVID.
Shingrix vaccine on June 19, 2023 by error; wrong vaccine administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 38-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19-JUN-2023, the patient received Shingrix. On 19-JUN-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Shingrix vaccine on June 19, 2023 by error) and wrong vaccine administered (Verbatim: wrong vaccine administered).  The outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   Additional Information: GSK receipt date: 01-SEP-2023 The patient was sent to the pharmacy to receive another vaccine. Patient is not immunocompromised. The reporter was a pharmacist intern who stated a 38 years old male patient received first dose of Shingrix vaccine by error, which led to inappropriate age at vaccine administration and wrong vaccine administered. The reporter did not consent to follow-up.
Parent RTC this AM with client.  C/O sorenss and swelling in L delt. Parent reports that client has 100 degree F temp last PM.  Back to norm with Tylenol. Client was examined by RN.  She states lymph nodes in L armpit were swollen, all lung fields clear.  RN advised ice and Tylenol per manufacturers direction and to seek immediate tx at Hospital if S/S worsen. Client to RTC on 9/11/06 for re-evaluation.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 11-NOV-2014, the patient was inoculated with ZOSTAVAX at a family health center for routine 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 25-OCT-2016, the patient was treated at the same family health center for painful symptoms and for the onset of a severe vesicular rash accompanied by weakened immunity, which was diagnosed as herpes zoster, or shingles. The patient was prescribed valacyclovir for management of her painful condition. 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.
Pt recvd vax 1Oct91. 30Oct91 devel joint pain primarily in the hands & feet. 6mos later diagnosed w/ stress fracture of rt foot while running. Has also occasional visual disturbance. No tx given. Slowly getting better.Also had h/a.
Loss of taste, extreme weight loss, headaches,  language usage and short term memory decline since booster.
symptoms worsened; Light headedness; Nausea; Vertigo; loss of appetite due to nausea,couldn't eat; couldn't walk due to nausea; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo), DECREASED APPETITE (loss of appetite due to nausea,couldn't eat), GAIT DISTURBANCE (couldn't walk due to nausea), DIZZINESS (Light headedness) and CONDITION AGGRAVATED (symptoms worsened) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included MULTIVITAMIN [VITAMINS NOS] and LINUM USITATISSIMUM SEED OIL (FLAX SEED OIL) for an unknown indication.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-May-2021, the patient experienced VERTIGO (Vertigo), DECREASED APPETITE (loss of appetite due to nausea,couldn't eat), GAIT DISTURBANCE (couldn't walk due to nausea) and NAUSEA (Nausea). On 06-May-2021, the patient experienced DIZZINESS (Light headedness). On an unknown date, the patient experienced CONDITION AGGRAVATED (symptoms worsened). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, VERTIGO (Vertigo), DECREASED APPETITE (loss of appetite due to nausea,couldn't eat), GAIT DISTURBANCE (couldn't walk due to nausea), DIZZINESS (Light headedness), CONDITION AGGRAVATED (symptoms worsened) and NAUSEA (Nausea) outcome was unknown. Not Provided          Concomitant products included MULTIVITAMIN [VITAMINS NOS] and LINUM USITATISSIMUM SEED OIL (FLAX SEED OIL)  Treatment mediation like IBUPROFEN was provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Non significant follow up received on 08-JUN-2021, No new information.
Information has been received from a health professional concerning a 3 year old male who on 27-JUL-2006 was vaccinated with VAQTA. On 24-Mar-2007, the patient began to stammer. The patient received the first vaccine of VAQTA on 27-Jul-2006 and had a similar response which resolved with time. As of 02-Apr-2007, the patient was recovering from his experience. Medical attention was sought. Additional information has been requested.
Patient reported feeling flushed, light headed and "motion sickness feeling" starting 5 minutes  post injection.
Body torso, upper chest to mid thighs, upper arms, itching, bright red rash all over body. Took Benadryl and felt fine.
Patient immunized approximately at 0748.  Patient complained of difficulty breathing and throat irritation while in waiting area.  Monitor personnel promptly identified patient?s condition and notified the team while staying with the patient ensuring she kept talking while the provider arrived.  Officer in Charge was notified during the process and was at patient?s side approximately 0756; provider followed within seconds.  Decision was made for immediate transport to ED.  While in route patient stopped talking, coughed and grabbed throat prompting CPT to deliver x1 dose of Epinephrine to left deltoid at 0758 with provider?s consent.  Shortly after dose administration patient resumed speech but continued to complain of dry and tight throat.  Patient was able to continued speaking reciting ABCs and personal information when prompted.  Patient did not experience altered mental status or loss of consciousness.  Arrived to Emergency Department (ED)  at 0805; report given to nurse and patient was checked in promptly.  ED provider plan included observation until 1100 and discharge pending follow up assessment.
Two hours after first dose of Moderna Covid-19 Vaccine I lost ALL hearing in my left hear and developed a VERY loud Tinnitus in both ears, as if a switch turned on to a LOUD ringing in my ears and it hasn't turned off. The hearing loss on the left ear was temporary and resolved on it's own within 24 hours. The tinnitus has NOT resolved. The tinnitus was mild before the vaccine and now after the vaccine it is severe and persists. Seven days after the injection I was started on a three week course of prednisone but it did not resolve the severe tinnitus.
Narrative: HISTORY OF RIGHT KNEE REPLACEMENT Symptoms: Dizziness & swollen R Knee
Feels like she's getting the flu after 2nd dose; Arm hurting really bad after 2nd dose; Arm swollen after 2nd dose; Arm hot after 2nd dose; Arm red after 2nd dose; Bad headache after 2nd dose; Fever of 101.4 F after 2nd dose; Fatigue after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Feels like she's getting the flu after 2nd dose), PAIN IN EXTREMITY (Arm hurting really bad after 2nd dose), PERIPHERAL SWELLING (Arm swollen after 2nd dose), FEELING HOT (Arm hot after 2nd dose) and ERYTHEMA (Arm red after 2nd dose) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 27b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced INFLUENZA LIKE ILLNESS (Feels like she's getting the flu after 2nd dose), PAIN IN EXTREMITY (Arm hurting really bad after 2nd dose), PERIPHERAL SWELLING (Arm swollen after 2nd dose), FEELING HOT (Arm hot after 2nd dose), ERYTHEMA (Arm red after 2nd dose), HEADACHE (Bad headache after 2nd dose), PYREXIA (Fever of 101.4 F after 2nd dose) and FATIGUE (Fatigue after 2nd dose). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, INFLUENZA LIKE ILLNESS (Feels like she's getting the flu after 2nd dose), PAIN IN EXTREMITY (Arm hurting really bad after 2nd dose), PERIPHERAL SWELLING (Arm swollen after 2nd dose), FEELING HOT (Arm hot after 2nd dose), ERYTHEMA (Arm red after 2nd dose), HEADACHE (Bad headache after 2nd dose), PYREXIA (Fever of 101.4 F after 2nd dose) and FATIGUE (Fatigue after 2nd dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.4 f (High) 101.4 F.         Treatment medications include Ice pack. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable. No relevant concomitant medications reported.
Moderna COVID-19 Vaccine EUA Patient received dose #1 of Moderna Vaccine on 1/20/2021, and dose #2 of Moderna Vaccine on 2/26/2021 from another Facility. The patient was admitted in 7/19/2021 with a diagnosis of Pneumonia due to COVID-19 virus. Patient expired on 7/23/2021 despite treatment with supplemental oxygen, steroids, and remdesivir.
Information was received from a physician regarding a 4 week old female patient. On 18-OCT-2013, the 4 week old patient was vaccinated with Liquid PEDVAXHIB, 0.5 ml, intramuscularly in the left thigh. On 18-OCT-2013, the patient was also vaccinated with ROTATEQ, 2 ml. No adverse effects reported at this time. Additional information is not expected.
patient was supposed to sign up for his first dose of the Moderna COVID-19 vaccine but accidentally signed up for the booster dose instead; No Adverse Event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (patient was supposed to sign up for his first dose of the Moderna COVID-19 vaccine but accidentally signed up for the booster dose instead) and NO ADVERSE EVENT (No Adverse Event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (patient was supposed to sign up for his first dose of the Moderna COVID-19 vaccine but accidentally signed up for the booster dose instead) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, WRONG PRODUCT ADMINISTERED (patient was supposed to sign up for his first dose of the Moderna COVID-19 vaccine but accidentally signed up for the booster dose instead) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (patient was supposed to sign up for his first dose of the Moderna COVID-19 vaccine but accidentally signed up for the booster dose instead).    No concomitant medications were reported.   Healthcare professional reported that, there was an incident at the store where a patient was supposed to sign up for his first dose of the Moderna COVID-19 vaccine but accidentally signed up for the booster dose instead. When he came to the pharmacy, per his paperwork he was administered a dose of the Moderna COVID-19 bivalent booster shot instead of his 1st dose. The patient did not report any adverse reactions.  No treatment details were reported.   Reporter did not allow further contact
The girl had high fever (38-40 degrees C). The pediatrician prescribed TYLENOL every 4 hours. Since I'm a new mother, I thought that it was normal although the fever lasted a little more than 1 week.
This is a spontaneous report from a contactable consumer who reported for herself.  A female patient of an unspecified age received PREVNAR 13 at 0.5 ml single in Mar2017 for immunisation. Patient stated that she had burning when pneumococcal 13-val conj vaccine went in; in Mar2017 she also had soreness in her arm and there was big redness and swelling in the arm (arm was a little bit flared up) . She had no fatigue, anaphylactic shock or anything like that. The patient's medical history and concomitant medications were not reported. The final outcome of the events was unknown.
Headache, fever, chills, body aches, extreme fatigue. Leg weakness, eyes burning
Neuropathy originates on the right side at the top of the head. Periodically radiating down as a "waterfall" .
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2013, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 18-JUL-2016, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as herpes zoster, or shingles. The outcome of the events is unknown. As a direct and proximate result of the 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. Additional information has been requested.
inconsolable screaming x 4 hrs then lethargic when awoke; fever of 102.5 w/APAP