chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Given DTAP #3 and Hep A #1 in left ant. thigh. Within 2 minutes she had a huge, red, swollen, hot area with fusing large hives on it, measuring about 11x11 cm. Child has cried a lot ever since (but also dislikes us and we have checked it a lot!). Given VERIPRED 20/5  tsp.., and BENADRYL 12.5.5 tsp. Observed.
Initial report received from a Licensed Practical Nurse on 21/Feb/2006.  A male patient, 26-28 years old with no prior egg allergies developed gastroenteritis signs and symptoms after eating eggs approximately two months after receiving Fluzone (lot number unknown) in the the deltoid, administered either in October or November 2006. The patient has not received the flu shot prior. It is not known if the patient had any illness at the time of vaccination. Per the reporter there is no further information available as this event was mentioned to her months ago and she can't remember the patient's name. Recovery status is unknown.
Fatigue, Malaise, Back Pain/Joint Pain - From 12/24 at 11 am to 12/25 at 6 pm
The patient received the Pfizer vaccine on 12/30/20 and 1/21/21 and was fully vaccinated when she tested positive for COVID-19 on 8/15/21.
24 hours after immunizations, developed L sided chest pain, worse on pressure being applied to the L parasternal area.  28 hours after immunization, involuntary tremors for 3 hours.  9/12/08 Reviewed hospital medical records of 8/28-8/29/08. FINAL DX: chest pain due to skeletal muscle injury; tremors of unknow origin Records reveal patient experienced intermittent left sided substernal chest pain day after vaccinations.  Developed dizziness & trembling.  Progressed well & was d/c but during d/c had recurrent chest pain.  Repeat labs & EKG WNL & d/c to home.
At 6/14/01 visit, mom described immunization reaction from 4/19/01 shots as "loud, high-pitched inconsolable crying for five hours and fever of 105F (R)." Mom states pt remained irritable for 24 hours. Mom described injection site (thighs) slightly red without swelling. No treatment by physician.
Presumed AIDP secondary to COVID-19 vaccination IVIG for 5 doses (7/8/21 to 7/12/21) Discharge to home post above completion
I have severe tinnitus 24x7 and sleep with a cochlear implant to lessen the noise so I can sleep.  I remove it when I awaken.  When I took it off THIS TIME, the noise was so loud and profound that I fell back on my bed, put my hands on my head, grabbed a hearing aid (near the bed) that allows some sound.  If that had no effect, I would've been non-functional.    I didn't report it at the time.  When I saw my internist for a yearly exam, I told her and did a follow-up in an email.  I wanted her to understand it how incapacitated I was.  I have a profound hearing loss (hence, the cochlear implant).  I have no doubt this was due to ototoxicity of the vaccination.
This is a spontaneous report from a contactable consumer (patient). A 33-year-old (non-pregnant) female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EW0162), at the age of 33, via an unspecified route of administration, left arm, on Apr 15, 2021, at 14:30, single dose, for COVID-19 immunisation. Medical history included COVID-19 on an unknown date in 2020 (four months prior to vaccination). The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, patient has not tested for COVID-19. Concomitant medications included Wellbutrin 150mg (bupropion hydrochloride) for an unknown indication, from an unknown date and unknown if ongoing. On Apr 16, 2021, at 10:00, patient experienced swollen lymph node under left armpit, chills, feeling unwell (10-36 hours after injection) and sore arm. The outcome of the swollen lymph node under left armpit, chills, feeling unwell and sore arm: recovering (at the time of this report). No follow-up attempts needed. No further information expected.
5 days after vaccination her right side of face became swollen, mild pain, when to urgent care, they prescribed augmentin 875mg and naproxen 500mg, she was ok after 2 days
Information has been received from a pharmacist via a Company Representative referring to unknown number of patients of unknown age and gender. Many patients had unspecified medical histories. On an unknown date in 2012, these patients were vaccinated with ZOSTAVAX (lot#, expiration date, dose, frequency and route were not reported). Concomitant therapies included influenza virus vaccine (unspecified). The reporting pharmacist reported that these patients experienced shingles on an unknown date in 2012 after receiving ZOSTAVAX and influenza virus vaccine (unspecified) concomitantly or within two 2 weeks of each other. Outcome of the events was unknown. Causality assessment was not provided. Additional information has been requested.
24 hrs. after receiving vaccine I developed orbital swelling. I currently still have the swelling despite antihistamines 4 days later. I also had fatigue, nausea, and site soreness that lasted 1 day after injection.
This spontaneous report as received from a healthcare worker refers to an unspecified number of unspecified patients of unknown ages and genders. On unknown dates the patients were vaccinated with doses of ROTATEQ (lot #, expiry date, dose, route and indication unknown) that were exposed to supported temperature excursions. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Stomach pains, gas, bloating, screaming uncontrollably 102 temp.
Initial and follow-up information has been received from a physician concerning a 11 year old female who on 20-AUG-2008 was vaccinated with the first dose of VARIVAX vaccine (Oka/Merck). Concomitant therapy included "tetanus" vaccine (manufacturer unspecified). It was reported that on 20-AUG-2008, at 8:30 am, the patient got a rash on her right arm after receiving VARIVAX vaccine (Oka/Merck) and tetanus vaccine (manufacturer unspecified). In follow-up information it was reported that the rash was circular (2-3 cm). The patient sought medical attention, saw the doctor. It was also reported that on 10-SEP-2008, at 8:30 a.m., the patient was vaccinated with a second dose of VARIVAX vaccine (Oka/Merck), Lot number 661636/0535X in the right upper arm. At the time of the report the patient's outcome was unknown. No further information is available.
Recipient of vaccination began having a reaction 30 minutes after receiving the shot. He presents with red welts and rash on back, RT AC site, redness to face and generalized itching to body. He was advised to go home and take diphenhydramine and shower and seek medical attention if symptoms worsen.
Overall Decline w/congestion and ABT tx,  Hospice Care, Crisis Care, Expired
Site: Pain at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Severe, Systemic: Chills-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Turning very pale, passed out and unresponsive, sweating-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Weakness-Medium, Additional Details: After 5 minutes of vaccination, mom called for help in the waiting area.  The patient passed out for a few minutes and responded after we both called her several times.  We called 911. She was feeling nauseous.  She sipped a little water and was looking very pale and was starting to become unconscious again.  Mother thought it was an allergic reaction and asked for Epipen.  Epinephrine was administered, and patient became alert and less pale.  EMS came and took her away due to low blood pressure
Mild headache and dizziness for 2 days, starting within 4 hours after receiving shot.  Mild to moderate fatigue starting 6 hours after shot and lasting for roughly 36 hours.  Chills and fever of roughly 100F, onset 14 hours after shot and lasting approximately 5-8 hours, reduced with 1 Advil.   Moderate arm soreness began 6 hours after shot was given and lasted for roughly 50 hours
Significant erythema of left deltoid area and shoulder 5/8in needle used for injection.  He had several bug bits on arm at the time of injection.
Redness & erythema (hot) for over 2 weeks after injection at injection site. Patient feels fine.
patient age three  should have received Dtap (daptacel), not Tdap (Adacel) Event entered as medication error.  Counter measures include leveraging electronic health record for a hard stop.
Pt recv vax on unknown day; 72 hr post vax pt exp rash & urticaria
Patient was given Tdap, Influenza and BEXSERO in this order. After the BEXSERO was given, patient had loss of consciousness. LOC lasted approx 1-2 minutes. Prior to LOC she was talking to me without difficulty.
Patient received Pfizer shot at 9:42am and walked up to the observation area, upon sitting she complained of dizziness and before the observing nurse finished wrapping the blood pressure cuff she became short of breath and then lost consciousness. she was transported to the hospital by EMS
Pt had a fever,  x 5 days, with a Tmax=103.9 on 8/1/13 followed by a rash (not seen by provider) from 8/1/13 until 8/4/2013. She had increased fussiness for all 5 days, a viral illness cannot be excluded.
stiff joints;crying for 9 hr-pt is not a big crier;swelling @ spot w/redness;
Information has been received from a registered nurse concerning a male child who was vaccinated with a first 2 mL dose RotaTeq vaccine after 12 weeks of age. No adverse affects. No other information. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
First felt "hot and dizzy" on 10 Mar.  Itchy at injection site on 12 Mar.  Dx's with cellulitis on 12 Mar and treated with Keflex.
Initial report was received 19 August 2010 from a health care professional. A 12-year-old male patient had received an injection of ADACEL, lot number U2936DA (Sanofi Pasteur Ltd. lot number C3170), and MENACTRA, lot number U3080AA, and VARIVAX (manufacturer Merck), lot number 06112 on 18 August 2010 and the following morning, he experienced swelling of the lips and eyelids, and a puffy tongue. He was seen by his physician and received BENADRYL as corrective treatment. He had no past medical history, no concurrent illness, and he had not been taking any concomitant medications. He had not received any other vaccinations within four weeks of ADACEL, MENACTRA and VARIVAX. At the time of the report, recovery status was reported as unknown. Documents held by sender: None.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2014, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult 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. In 2015, the patient was treated at a clinic for a persistent vesicular outbreak accompanied by weakened immune symptoms, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of 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.
This spontaneous case was reported by a consumer and describes the occurrence of SEXUAL DYSFUNCTION (Effect sex life) and VERTIGO (Vertigo) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. No Medical History information was reported. On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, 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 experienced SEXUAL DYSFUNCTION (Effect sex life) and VERTIGO (Vertigo). The patient was treated with DIMENHYDRINATE (DRAMAMINE) at an unspecified dose and frequency. At the time of the report, SEXUAL DYSFUNCTION (Effect sex life) and VERTIGO (Vertigo) outcome was unknown. Action taken with mRNA-1273 in response to the event was not applicable. No Concomitant Medication was provided. Dramamine motion sickness band used as a Treatment Medication.
patients received vaccines after exposure at low temperature; This non-serious case was reported by a physician via call center representative and described the occurrence of incorrect product storage in an unspecified number of patients who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis, HBV (Engerix B) for prophylaxis, HAV (Havrix) for prophylaxis, DTPa (Infanrix) for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, Men ACWY-CRM NVS (Menveo) for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis and Rota (Rotarix liquid formulation) for prophylaxis.   On an unknown date, the patient received Bexsero, Boostrix, Engerix B, Havrix, Infanrix, Kinrix, Menveo, Pediarix and Rotarix liquid formulation. On an unknown date, an unknown time after receiving Bexsero, Boostrix, Engerix B, Havrix, Infanrix, Kinrix, Menveo, Pediarix and Rotarix liquid formulation, the patient experienced incorrect product storage (Verbatim: patients received vaccines after exposure at low temperature). The outcome of the incorrect product storage was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 27-JUN-2023 The physician reported that the patients received Bexsero, Boostrix, Engerix B, Havrix, Infanrix, Kinrix, Menveo (2 vials), Pediarix and Rotarix (reconstituted) after below temperature excursion, temperature was minus 0.1-degree C. The reporter did not had data on the patients or vaccines administrated. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up. The patients received vaccines after exposure at low temperature, which led to incorrect product storage.
Recieved Moderna COVID-19 vaccine which had undergone multiple temperature excursions; Recieved Moderna COVID-19 vaccine which had undergone multiple temperature excursions; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Recieved Moderna COVID-19 vaccine which had undergone multiple temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (Recieved Moderna COVID-19 vaccine which had undergone multiple temperature excursions) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Recieved Moderna COVID-19 vaccine which had undergone multiple temperature excursions). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Recieved Moderna COVID-19 vaccine which had undergone multiple temperature excursions). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Recieved Moderna COVID-19 vaccine which had undergone multiple temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (Recieved Moderna COVID-19 vaccine which had undergone multiple temperature excursions) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter.  Patient received vaccine in question as a booster dose. It was not known which arm the patient received the vaccine. The Nurse reported no adverse reactions or side effects to the Moderna Covid-19 vaccine.  On 3-Mar-2022 vials were moved from freezer to refrigerator. Vials were refrigerated at the time of the excursion. There were multiple temperature excursions as reflected above. Maximum Temperature was 49 degrees Fahrenheit, Minimum Temperature was 37.7 degrees Fahrenheit. The temperature excursions occurred on 4MAR2022, 5MAR2022, 7MAR2022, 8MAR2022, 8MAR2022, 9MAR2022, and 10MAR2022.    Treatment information was not provided.
a slight fever; stomach was bothering; appetite wasn't there; This is a spontaneous report from a contactable consumer. This consumer (Patient's Husband) reported for a patient (his Wife) that a female patient with unspecified age started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. Patient's medical history and concomitant medications were not reported. Consumer mentioned in passing his wife has side effects after vaccine but were less severe than his. Did not notice AE during call, so did not offer transfer back to DSU, unsure if she was included in the AE report. Consumer questioned that if one can wait six weeks to get second dose. Information was provided as per CONS attached and referred back to HCP. Patient's husband (reporter) received first dose of the Pfizer BioNTech Covid 19 vaccine approximately 3 weeks ago from his place of employment. In Feb2021 he tested positive for Covid and was hospitalized for three days due to a pulmonary embolism. Two days after receiving his first dose of the vaccine, he started developing symptoms, he felt like he was getting Covid again. He experienced a slight fever, stomach was bothering him, appetite wasn't there and it took two weeks to recover. The consumer questioned 'Why do the side effects of the vaccine feel so much like Covid. ' He stated that his wife had same side effects but less severe. (recognized this potential AE after call, did not obtain her age, not sure if this was transmitted to DSU when he initially reported side effects. He further questioned 'Is there any study going on about the efficacy after one dose? Didn't "another country" talk about doing a study on one dose on the variants but ended up not doing it. Did did one hospital say that the Pfizer vaccine was 80% effective in people who have already had covid?'' Information as per CONS attached and referred back to HCP. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Nosebleed that would not stop for over 4 hours, went to ED and INR was 9.43.  Usual INR is 2.5.  Discontinued Warfarin for 4 days, had INR rechecked on 2/3 it was 1.9.
I received my COVID19 booster on 10/15/21 in my right arm.  On Sunday 10/17/21 I had pain in my armpit (lymph node), also a severe headache.  I started taking 500 mg Acetaminophen on Sunday, however it wasn't really giving my any relief.  This lasted until 10/20/21 around 4:30 pm.  I was told by our nurse at the COVID19 command center to report these events.
Joint pain; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of ARTHRALGIA (Joint pain) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Joint pain). At the time of the report, ARTHRALGIA (Joint pain) outcome was unknown. Not Provided      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.   Concomitant product use was not provided. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Non-significant information received (consumer's email).
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Pharmacist reported that an expired dose of GARDASIL INJ (Lot # 668260/1570Z and expiration date 04/06/2013) (dose and route were not reported for prophylaxis, was administered to a patient on 21-JUL-2013. Concomitant medications were not reported. No adverse effect reported. Additional information has been requested.
"Bad" upper jaw infection; Chills; Fatigue; A spontaneous report was received from a consumer concerning 68-years-old, white female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced "Bad" upper jaw infection, chills and fatigue.  The patients past medical history included: COPD, Periodontal disease, Jaw infection. The following drugs are known to have been taken by the patient prior to the event: Vitamins.  On 17-Jan 2021, the patient received their first of two planned doses of mRNA-1273 (lot: 032L20A) and on 25 Feb 2021, the patient received second of the of the two planned doses of mRNA-1273 (lot: 023M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 26 Feb 2021, the next morning after the second injection, the patient experienced chills and fatigue that eventually resolved on an unknown date. On 01 Mar 2021, the patient reported that she went to the dentist and was diagnosed with a "bad" upper and lower jaw infection. She reported that the jaw infection was painful, and she was prescribed an unknown antibiotic (seven-day treatment).  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events is not applicable.  The event of "Bad" upper jaw infection was unresolved, while the event of chills and fever were resolved.  The reporter did not provide an assessment for the events "Bad" upper jaw infection, chills and fatigue.; Reporter's Comments: Based on the current available information the event of Bad" upper jaw infection is assessed as unlikely related to mRNA-1273 use.  Event is most likely attributed to the underlying history of Periodontal disease, Jaw infection.  The events of fatigue and chills are consistent with the known safety profile of the vaccine, as such a causal association cannot be excluded.  However, causality is also confounded by the ongoing infection..
Patient was vaccinated and I do not have access to the Lot number. Patient reports sudden onset of linear, hyperpigmented, flat rash on middle of chest and down right breast. It is sensitive feeling like a mild sunburn. It started approx 60 hours after her COVID Moderna Vaccine dose #2.  She was assessed over a video visit today and is having an in-office evaluation tomorrow morning.  She had the typical low grade fever and fatigue for the first 48 hours after the vaccine and that has since resolved.