chrisvoncsefalvay/vaers-outcomes huggingface dataset:
25 Mar 21 Nausea 10 minutes after shot, within 24 hours after shot right arm sore, 20 to 25 days after shot arm continues to be sore pain worsen.  Around the end of Jun 2021 start to have problems with motion of right arm.  Starting in early Jul right arm goes numb sometime and drop things if holding them in right hand.  Can't lift right arm as before the shot.
Site: Itching at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Additional Details: Administered Zyrtec 10mg and monitored patient for 45 mins since vaccination.  Symptoms did not worsen and patient attributed it possibly to an allergy shot she received.  Will follow up later this evening.
fatigue started 8 hours after shot followed by a high fever 103-104, headaches, stomach pain, child taken to emergency room at 1am, vomited several times, given zofran which helped, continued with high fever the next day that was controlled by tylenol and motrin, decreased appetite but no more vomiting.
Pt developed painful erythema of (R) deltoid which migrated down her arm 5/16/12 cellulitis and abscess of upper arm and forearm. Treated w/ cephalexin 250mg QID x 10 days.
When patient arrived in nurse's office, she stated she had experienced tingling in face, lips, and hands with the first dose.  Patient chose to continue with vaccination series and receive second dose.   She brought a personal Epi-pen and oral Bendadryl as contingencies.  Vaccination was given.  Patient remained in nurse's office and 6 minutes post vaccine administration she began to state that she was experiencing tingling in her face, hands, arms.  Within minutes, patient also stated that her throat was beginning to feel tight.  When asked if she wanted to administer her Epi-pen, she refused.  She then self-administered a single dose of oral, OTC Benadryl 25 mg.  Nurse asked if she wanted paramedics to be called and patient refused.  Within a few minutes of self administration of the Benadryl, she stated she felt her throat was constricting further.   Nursed then called 911 and continued to monitor patient until paramedics arrived.  Patient was again asked if she would take her Epi-pen and she refused again.  Patient stated that Benadryl had always been sufficient to control allergic reactions in the past.   Vitals:  BP 139/90 Pulse 98 Temp 98.0 Respiration rate was impossible to ascertain because patient was breathing irregularly.  Paramedics arrived and assessed the patient.  Patient stated that she was feeling better and refused to be transported to the hospital.    Patient remained in clinic until her spouse arrived and transported her home at approximately 10:45am.
I have had aching to the bone in my left femur-intermittent left sciatica- pain in both knees for 5 months seen Chiroprator 6 times in 5 weeks
Arm is sore, to do any lifting. Can feel it all the time. Constant pain.
This is a spontaneous report from a contactable healthcare professional. A 43-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, lot number: EK9231; expiration date not provided), via an unspecified route of administration on 15Jan2021 07:40 at a single dose for COVID-19 immunisation. Medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. Concomitant medications were not reported. The patient reported that she was having some side effects from the second dose of the Covid vaccine. On 15Jan2021, within 1 hour, the patient started having a low-grade fever and very nauseous. Also, the patient stated that she "feels awful". She didn't experience this with my first dose. The outcome of the event feels awful was unknown, while the outcome of low-grade fever and very nauseous was not recovered.
Pt recvd vax & devel fever which lasted a couple of days & an inject site react which included redness & swelling; recovered;
Pt was here for 6mo PE. After PE was done I gave 6mo shots. Gave ROTATEQ first, then PCV13, after I was done giving Hep B pt was crying so hard he turned blue, eyes rolled in back of head & was limp. I ran & got Dr. Came in and suctioned his mouth out, got vitals they were good. Sent him to ER for observation. Did not give PENTACEL.
Woke up in middle of night severely nauseated, sinuses swollen, when awake, feeling unwell and tired; Woke up in middle of night severely nauseated, sinuses swollen, when awake, feeling unwell and tired; Woke up in middle of night severely nauseated, sinuses swollen, when awake, feeling unwell and tired; Woke up in middle of night severely nauseated, sinuses swollen, when awake, feeling unwell and tired; This is a spontaneous report received from a contactable Consumer via COVAES. A 42-year-old non-pregnant female patient (not pregnant) received bnt162b2 (BNT162B2, Solution for injection Lot number: EW0186), via unspecified route of administration, administered in arm left on 19May2021 16:00 at the age of 42 years as dose 1, single for covid-19 immunisation at Pharmacy or Drug Store. Relevant medical history included Asthma and sulfa (Sulfonamide allergy). Concomitant medications included: escitalopram oxalate (LEXAPRO) and (cetirizine hydrochloride) Zyrtec. Patient previously took Codeine and Aspirin, experienced allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient did not test for COVID-19. On 20May2021, 02:00, patient woke up in middle of night severely nauseated, sinuses swollen, when awake, feeling unwell and tired. Therapeutic measures were not taken as a result of fatigue, nausea, sinus pain, malaise. Outcome of the events was recovered on an unknown date. Follow-up attempts are completed. No further information is expected.
Patient got pale, diaphoretic and pasted out for approx. 15 sec., after 5 min after getting the injection. Patient aroused.  She reports that she had not eaten anything today.  Given graham crackers and water for oral intake.  Shortly after eating the crackers and drinking the water, patient vomited.  She reports that she felt better after the emesis.  Patient able left per ambulatory status, after 30 min of monitoring patient.
Patient received expired Moderna Covid-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-May-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine). On 18-May-2021, EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medication was reported. Treatment information was not provided.
Nurse reported the patient received an improperly stored dose of PROQUAD; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs, drug reactions and allergies was not provided.  On 07-JAN-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # S021327 expiration date 05-JAN-2021 (dose, route and anatomical location were not provided) for prophylaxis. The vaccine was exposed to a temperature of - 9 degree celsius to 8 degree celsius (-3 degree celsius) during 30 minutes. There was not previous temperature excursion. It was reported that digital data logger was involved. Additionally, the vaccine was reconstituted with sterile diluent lot # R032353 expiration date reported as 10-JAN-2021, but upon internal validation established as 10-JUN-2021.
Immunizations Hep A and Variavax given. Left arm swollen 6cm area at injection site.
Exactly 7 days after I received the vaccine my injection site starting itching. The itching turned into hives. When I woke up on the 8th day the injection side was red, hot, grew to the size of my fist & is very swollen underneath in my muscle. It is hot, red, & itchy.
pt recvd Engerix-B & 1 1/2 hrs p/dose had vomiting, diarrhea, nausea, fever, dizziness;
first dose of Shingrix on Dec. 12. / itchy feeling on my body; This case was reported by a consumer via interactive digital media and described the occurrence of generalized pruritus in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th December 2020, the patient received the 1st dose of Shingrix. On 16th December 2020, 4 days after receiving Shingrix, the patient experienced generalized pruritus. On an unknown date, the outcome of the generalized pruritus was unknown.   It was unknown if the reporter considered the generalized pruritus to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient himself/herself. The age group was not reported but was captured as adult as per vaccine indication. The age at vaccination was not reported. The patient experienced itchy feeling on the body. The patient wanted to know if this could had been caused by the vaccine. The follow-up would not possible as no contact details were available.
In June after my second dose I was in bed at home ill, I had a three to four day effect after the second dose-A really bad flu-fever, aches pains, chills, fatigue, had to miss three days of work.
During their appointment, the patient told the provider he only had received two doses of Covid vaccine. Provider then checked on system and reported seeing only two doses received of Moderna so the provider told the MA to give the patient his booster shot since he was due. After the MA received the instruction to give the booster vaccine to the patient, the MA gave a Pfizer booster dose to the patient. After it was discovered that the patient had already received his booster on 1/7/22, the provider spoke to the patient about the incident and checked with patient to see how they were doing. The patient reported feeling fine.
Rhabdomyolysis, CPK 5070 U/L (normal range <308 U/L) on Feb 3, 2021.  Diffuse sore muscles after extreme work out on both 1/30 & 1/31.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Oct2021 as dose 2 (booster), single (Lot number: 320308D) at the age of 49 years for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 01Apr2021 as dose 1, single (Lot number: 042A21A) for covid-19 immunisation. The patient's relevant medical history included: "seronegative spondyloarthropathy" (unspecified if ongoing), notes: Other medical history: seronegative spondyloarthropathy. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL (dose and route were not reported), lot # K006117, expiration date 14-JAN-2017; K009482, expiration dat e 06-MAR-2017; K011492, expiration date 22-JUN-2016; L001442, expiration date 04-NOV-2016 and lot # reported as K006396, expiration date 04-MAY-2016. Total number of doses administered was 39. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
She was given the flu shot on 10/13/15 and started reacting to it shortly afterwards. Her arm started to feel numb from her shoulder down to her fingertips. She couldn't grasp anything in her left hand. Strange feeling went up her left side of her neck into the left side of her jaw. That lasted for two days. After two days she had diarrhea.
Experienced intense pain in joints and muscles on 1/27. During the next 2-3 weeks, pain moved to other joints and muscles. Intensity varied. Applied ice to back of knees and legs when movement was affected. As the weeks progressed, fatigue, weakness and pain became more intense. It became difficult to stand from a sit position, walk, turnover in a lying position, bend-over and sit-down. PCP ordered labs on 3/08, which resulted in ESR and CRP showing elevated, inflamed condition. Referred to rheumatology. Diagnosed on 4/21 with polymyalgia rheumatica. Prescribed prednisone 15mg/day. Symptoms relieved and strength returned. Gradual tapering off of prednisone is planned.
COVID-19 - acute hypoxemic respiratory failure. ED visit to hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.
administration of improperly stored vaccines; This spontaneous report was received from a medical assistant referring to a 4 years old patient of unknown gender. Concomitant therapy included sterile diluent. Information about pertinent medical history and drug reaction/allergy was not provided.      On 27-AUG-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (lot # T002848, expiration date 23-JAN-2022; strength, vaccine dosage detail and route of administration were not reported) for prophylaxis (product storage error). Current temperature excursion was 6 Fahrenheit degrees to 14 Fahrenheit degrees (10.56 Fahrenheit degrees) for 50 minutes. Previous temperature excursion was 6 Fahrenheit degrees to 14 Fahrenheit degrees (8.47 Fahrenheit degrees) for 30 minutes. No product quality complaint (PQC) was identified. Data logger was involved.
Initial report received from a health care professional on 28 October 2011. A 61-year-old female patient received an intramuscular left deltoid injection of FLUZONE, sanofi pasteur lot number UH486AE, on 18 October 2011 at 10:00 AM. The patient had an allergy to penicillin. The patient's concomitant medications included hydrochlorothiazide, lisinopril and ezetimibe and VYTORIN. The patient's medical history was not reported. The patient received a flu vaccine every year. She had no illness at the time of vaccination and had no prior adverse events following previous vaccinations. On 18 October 2011, two hours after vaccination at 12:00 PM, the patient had tingling in the mouth, throat swelling, fever, and chills. She went to the Emergency Room (ER) and was given BENADRYL, prednisone and ZOFRAN. The patient was sent home a few hours later. The outcome was reported as recovered. Documents held by sender: None.
Patient received a pneumococcal vaccine (in left thigh), an influenza vaccine (in left arm) and his 3rd hepatis A&B vaccine of the series (in left thigh) on 11/3/08.  Later that night, patient developed warmness, swelling, redniess, and itching involving the whole left anteromedial thigh.  Patient also had fever for 1 day.  Veteran had received his previous 2 doses of hepatitis A&B on 5/14/08 and 6/13/08 without incident.  Had received influenza vaccine in previous years without incident.  Patient was prescribed cephalexin 500 mg qid x 10 days as he also had an elevated white blood cell count.
Information has been received from a registered nurse concerning a 13 year old female with no reported medical history who on 09-NOV-2007 was vaccinated with 0.5 ml of Gardasil (Lot #659439/1267U) intramuscularly.  Concomitant therapy included MENACTRA (route and site of administration not reported) on the same day.  The patient fainted shortly after receiving the Gardasil shot.  The patient was observed for 60 minutes in the office following the fainting.  No further information was available.  The patient recovered on an unspecified day in November 2007.  Additional information has been requested.
Patient received a Moderna booster at the pharmacy today, it was discovered their 2nd Moderna was on 8/13/2021. The patient was ineligible for their booster dose until 2/19/2022.
Rash; bad nausea; swollen lymph nodes; hard; This spontaneous case was reported by a consumer and describes the occurrence of INDURATION (hard), RASH (Rash), NAUSEA (bad nausea) and LYMPHADENOPATHY (swollen lymph nodes) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced INDURATION (hard), NAUSEA (bad nausea) and LYMPHADENOPATHY (swollen lymph nodes). On 20-Feb-2021, the patient experienced RASH (Rash). At the time of the report, INDURATION (hard), RASH (Rash), NAUSEA (bad nausea) and LYMPHADENOPATHY (swollen lymph nodes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
On day 9 after first dose, I developed an itchy red patch at the injection site. On day 10 it is still there; it is itchy around the edge of the red patch, but the red patch itself is now sore to the touch and warm to the touch.
No additional AE; HBP reporting that PROQUAD was administered after it experienced a supported temperature excursion. No side effects reported from HBP.         ?    Names of vaccines involved (including lot/exp): PROQUAD, Lot: W036940, Expiration: 4/15/2024; This spontaneous report as received from an unspecified source also reported as "HBP" referring to a patient (gender and age not reported).  No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 12-JUL-2023, the patinet was vaccinated with a second dose of an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) RHA, which had a valid lot # W036940, at a dose of 0.5 milliliter, along with sterile diluent; for prophylaxis, however no adverse effects were reported.   Administered dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) experienced the temperature excursion below 8.6 degrees Celsius (-8.6C) for 51 minutes. Digital data logger was not involved. There were previous temperature excursions reported as: -11.5 C for 1 hour, 16 minutes, 0 seconds.
Initial unsolicited report received from the literature on 15-Sep-2017. This case is linked with: 2017SA173163 (same literature). Abstract: This is the second phase 1 study of a respiratory syncytial virus (RSV) vaccine containing RSV fusion protein (sF) adjuvanted with glucopyranosyl lipid A (GLA) in a squalene-based 2% stable emulsion (GLA-SE). In this randomized, double blind study, 261 subjects aged _60 years received inactivated influenza vaccine (IIV), a vaccine containing 120 _g sF with escalating doses of GLA (1, 2.5, or 5 _g) in SE, or a vaccine containing 80 _g sF with 2.5 _g GLA in SE. Subjects receiving 120 _g sF with 2.5 or 5 _g GLA were also randomized to receive IIV or placebo. Immunity to RSV was assessed by detection of microneutralizing, anti-F immunoglobulin G, and palivizumab-competitive antibodies and F-specific gamma interferon enzyme linked immunosorbent spot assay T-cell responses. Higher adjuvant doses increased injection site discomfort, but at the highest dose, the reactogenicity was similar to that of IIV. Significant humoral and cellular immune responses were observed. The 120 _g sF plus 5.0 _g GLA formulation resulted in the highest responses in all subjects and in older subjects. These results confirm previous observations of vaccine tolerability, safety, and immunogenicity and were used to select the 120 _g sF plus 5.0 _g GLA formulation for phase 2 evaluations. This case involves 69-year-old female patient, who was vaccinated with a dose of INFLUENZA VACCINE and dose of 120 microgram of RESPIRATORY SYNCYTIAL VIRAL VACCINE (batch number, expiry date, dose, dose in series site and route of administration were not reported) on an unknown date. The patient's medical history and concomitant mediation was not reported. On an unknown date, 58 days following the vaccination patient had invasive ductal breast carcinoma. The patient laboratory data and corrective treatment were not reported. Outcome of event was not reported. As per the reporter relationship to study dosing was reported as not related. Upon internal review the case was considered as serious because of important medical event: invasive ductal breast carcinoma. List of documents held by sender: none. Sender's Comments: This case concerns a 69 year old female who developed invasive ductal breast carcinoma 58 days post vaccination with Inactivated Influenza vaccine (MFR unknown). Time to onset is compatible with the role of vaccine. Further information including patient's medical history, concomitant medications, previous vaccination and tolerance, additional information regarding patients' medical condition at the time of vaccination would be needed to fully assess this case. Also as FLUZONE along with respiratory syncytial virus (RSV) vaccine [containing RSV fusion protein (sF) adjuvanted with glucopyranosyl lipid A(GLA) in a squalene-based 2% stable emulsion (GLA-SE)] were administered concomitantly the role of each cannot be assessed separately.
PT C/O L SCAPULA PAIN W/ FEELING OF SWOLLENESS AFTER RECEIVING MODERNA VACCINE. PT WAS BEING MONITORED FOR 30 MINS, D/T PAST ALLERGIC REACTION TO YELLO #4 AND BEE STINGS. AFTER 30  MINS PT'S R SHOULDER AREA SHOWED SWELLING TOWARDS NECK. 911 RESPONSE WAS INICIATED, VITALS WERE WNL. PT WAS TRANSPORTED TO THE HOSPITAL.
Administering of vials after potential product storage error; A spontaneous report was received from a healthcare professional concerning a patient who received Moderna's COVID-19 Vaccine (mRNA-1273) while the vials were left out at room temperature for 2 hours.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, approximately 0 days prior to the onset of the event, the patient received a dose of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, 12 vials were left out at room temperature for 2 hours. The vials were administered to 20 patients on an unknown date. There was no reported information regarding where the vials were stored once they were thawed for 2 hours. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The event, administering of vials after potential product storage error, was considered resolved on an unknown date.; Reporter's Comments: This case concerns a patient who received a dose of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection and the vials were left out at room temperature for 2 hours. There were no reported adverse events after the vaccine was administered in the case of product storage error
Shortness of breath Shivers Extreme cold Pin pain in lungs (very sharp - sword feeling) Exhausted  Thirsty