chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from retired nurse also reported as healthcare worker via company representative concerns a female patient in her sixties years of age who was referring to herself. Medical history was not reported. On an unspecified date in 2006, the patient was vaccinated with ZOSTAVAX (dose, units, dose number, anatomical location, route of administration, and lot number were not reported). Concomitant medications were not reported. On an unspecified date in fall 2013, the patient developed shingles. The patient developed the shingles in face and eye area. The patient received treatment from Urgent Care Facility from which she had retired. On unspecified date in 2013, the patient was also referred to optometrist as the shingles was also in the eye (area of side not specified). The reporter stated that the patient did not develop PHN (post-herpetic neuralgia) commonly associated and has since recovered (date unspecified). The patient was treated with antiviral drugs (manufacturer unspecified, dose unspecified) and Prednisone (manufacturer unspecified, dose unspecified). The patient did not seek medical attention. The outcome of the reported events was reported as recovered (date unspecified). The relatedness between provided events and ZOSTAVAX was not reported. Additional information has been requested.
so sick; BP has been elevated; headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (so sick), HYPERTENSION (BP has been elevated) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (so sick), HYPERTENSION (BP has been elevated) and HEADACHE (headache). At the time of the report, VACCINATION COMPLICATION (so sick), HYPERTENSION (BP has been elevated) and HEADACHE (headache) had not resolved.            No concomitant and treatment information were reported.
Patient was administered immunization. When patient went to switch places with mom. Patient fell to floor. Patient was sweaty, clammy and hot. Patient was able to sit up and patients BP was very low. EMS did arrive and administered IV fluids and monitored closely.
Two days of chills and fever. Arm swelled a little, itched and had a rash for about 5 days on the arm.
hives; rash; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for self that the female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 24Mar2021 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced hives on an unspecified date with outcome of unknown, rash on an unspecified date with outcome of unknown, she was given a prescription for 5 days of steroid. she also mentioned that she read online that steroids can affect the efficacy of the vaccine on an unspecified date with outcome of unknown, she was given a prescription for 5 days of steroid. she also mentioned that she read online that steroids can affect the efficacy of the vaccine on an unspecified date with outcome of unknown. Consumer is about to take their 2nd dose of the PFIZER-BIONTECH COVID-19 VACCINE and wanted to know if she is able to take steroids alongside the vaccine that has been prescribed to her for hives and rash (for 5 days) . Also, she would like to know; if she's able to do that, if it would affect the efficacy of the vaccine and if not, does she have to repeat the whole vaccination series. Also, consumer went to her physician and she was prescribe of this steroid for her hives and rash, but physician does not believe this to be a side effect of taking the vaccine because she did not develop the hives and rash not later than 15 days after her vaccination. Consumer reported that she received the 1st dose of covid-19 vaccine last 24Mar2021. She had hives rash after the vaccine but not sure if it's because of the vaccine. She mentioned that she was given a prescription for 5 days of steroid. She also mentioned that she read online that steroids can affect the efficacy of the vaccine. She wanted to ask if this is true and she also wanted to know if it's okay to take the steroid. The 2nd dose scheduled on 15Apr2021, which is more than 21 days.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
1.) Fever to 101.8F, chills, nausea, vomiting, onset 12 hours after vaccine, lasted for 24 hours. 2.) Macular Rash on anterior chest; onset 24 hours after vaccine, resolved. 3.) Symptoms fully resolved 48 hours post vaccine.
Loss of smell for 24 hours; Nasal congestion; This spontaneous case was reported by an other health care professional and describes the occurrence of ANOSMIA (Loss of smell for 24 hours) and NASAL CONGESTION (Nasal congestion) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Medical history not reported).    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced ANOSMIA (Loss of smell for 24 hours) and NASAL CONGESTION (Nasal congestion). On 09-Jan-2021, ANOSMIA (Loss of smell for 24 hours) and NASAL CONGESTION (Nasal congestion) had resolved.        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 medications were not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Arthralgia, Rash, flare up of chronic conditions - psoriasis and psoriatic arthritis. psoriasis rash on scalp, shins, arms, torso. Arthralgia over ,ankle, shoulder, and back.  Narrative: She describes that she is not on medications for psoriasis or psoriatic arthritis prior to receiving vaccine. she had minimal flare ups with psoriatic rashes, did not require medications. 2 days after received 1st dose of vaccine, she woke up with severely pruritic psoriatic rash on her scalp. She also started experiencing left ankle pain with limited ROM. She had a telehealth visit with her rheumatologist on 6/9 - was told symptoms likely related to vaccine. Left ankle is swollen, painful, limited motion. she was offered systemic prednisone or localized steroid injection. She opted for systemic prednisone, started taking 6/12 on prednisone (80 mg x 7 days) then supposed to call provider's office at the end of the week with an update. She will call on Friday to get additional information as to how to taper prednisone. She is on day 3 of prednisone  80mg daily. She notes that she has not experienced much change in joint pain or swelling.
48 hours post vaccination, knuckle pain in all fingers and at day +14 pain/inflammation has not subsided.  Due to other rare side effects of Janssen vaccine, have avoided over the counter medications that may increase risk of blood clotting. However, have taken aspirin and/or tylenol during these 14 days and neither seems to assist in decreasing pain/inflammation.   Knuckles are not swollen but are sore/sometimes tender and painful to make a tight fist.   No physical injury occurred to any knuckles at or around the time of the vaccine, so the only connection to this pain/inflammation is the vaccine itself.
Received varicella vaccine in doctor's office on 01/08/2003. Did not have any systemic or local reaction at that time. On 6/23/04 developed vesicular rash with pain on left shin. On 6/24 rash had circled up leg, over knee, around thigh to lower left buttock. Seen by doctor. Diagnosed with Shingles (Herpes Zoster). Started on 6/23/04. 6/28/04: rash is resolving, but not completely gone yet.
10/15 shot given approx. 1:30 PM. About 3:30 extremely dizzy, unable to walk safely. Nausea and mental confusion. Extreme discomfort which continued throughout next day 10/16. Around sunset began to recover and finally did 10/17 morning. This Flu shot will be my last one, at 70 don't want to die next time from a second Flu shot.
Headache upon waking; General joint pain; Burning in the armpits; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Burning in the armpits), HEADACHE (Headache upon waking) and ARTHRALGIA (General joint pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Patient has large complexion.  Concurrent medical conditions included Gluten sensitivity and Dairy intolerance.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Burning in the armpits), HEADACHE (Headache upon waking) and ARTHRALGIA (General joint pain). At the time of the report, VACCINATION SITE PAIN (Burning in the armpits), HEADACHE (Headache upon waking) and ARTHRALGIA (General joint pain) outcome was unknown.      No concomitant medication details were provided. No treatment medication details were provided.   Reporter would like to be guided on what to do to eliminate intense pain in the elbow and how or what to do to eliminate the general pain.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-619929:Husband case
Single dose of IPV and Pediarix were given at the same time.  No adverse outcome.
Approximately 3-5 weeks after getting my seasonal influenza vaccine, as required by my work as a physician, I started to develop vague left hand arthralgias that rapidly progressed to migratory paresthesias largely involving my left arm, lower extremity and face.  There was no muscle weakness, but with progressing paresthesias, I ended up in urgent care for concern of a stroke.  Symptoms remained heightened for an additional 2 weeks and then settled down, only reoccur with the same level of intensity beginning 11/20/2020.  No facial involvement, just left upper and lower extremity neuropathy.  Right side is generally spared, but has had some mild paresthesias involving the dorsum of my right foot primarily.
Patient states cannot lift arm above shoulder, swelling around shoulder. Pt has iced/taken TYLENOL with no improvement.
Mom reports that this child was with her father and developed a fever Friday night. Told her that took her to ER but labs found out that not. Temperature 103 at that time. Father took her home around 3:00 am. Mom reports that was ok when got out of bed and then noticed her jerking her head. Took her to rescue squad and transported to hospital via ambulance.
had a little leg swelling; baby had been non-stop crying/screaming ever since receiving the vaccines; Initial information received on 21-Apr-2022 regarding an unsolicited valid non-serious case was received from a physician.  This case involves a 2 month old male patient who had a little leg swelling and baby had been non-stop crying/screaming ever since receiving the vaccines diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine [Pentacel], pneumococcal vaccine conj 7v (crm197) [Prevnar] and roto liquid.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 20-Apr-2022, the patient started taking PREVNAR (PNEUMOCOCCAL VACCINE CONJ 7V (CRM197)) Unknown formulation dosage unknown (with an unknown batch number and expiry date) in left leg for Prophylactic vaccination, unknown dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number and expiry date: not reported) via unknown route in left leg for Prophylactic vaccination and roto liquid dosage unknown (with an unknown batch number and expiry date) for Prophylactic vaccination. Information on batch number was requested.  On 20-APR-2022 the patient developed a non-serious "had a little leg swelling (vaccination site swelling)" same day following the first dose intake of PNEUMOCOCCAL VACCINE CONJ 7V (CRM197), DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE and roto liquid.  On 20-APR-2022 the patient developed a non-serious "baby had been non-stop crying/screaming ever since receiving the vaccines (crying)" same day following the first dose intake of PNEUMOCOCCAL VACCINE CONJ 7V (CRM197), DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE and roto liquid.  It was reported "Patient: 2 month old male patient Product: Pentacel Event(s): Wednesday, 4/20/22, patient was vaccinated with Pentacel, Prevnar and Roto liquid around noon, left leg. Parent called afterhours number around 9pm and reported that the baby had been non-stop crying/screaming ever since receiving the vaccines. The baby also had a little leg swelling. Parent did state that the baby slept an hour or two but when awake began to cry/scream again. Physician shared that she was in touch with the parent multiple times throughout the evening and night. She also saw the baby first thing this morning and the baby seemed fine. The baby was no longer crying and didn't seem to have any swelling or redness of the left leg. Physician is ok to receive follow up."  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL), PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and roto liquid was not applicable.  It was not reported if the patient received a corrective treatment for the events (had a little leg swelling, baby had been non-stop crying/screaming ever since receiving the vaccines).  At time of reporting, the outcome was Recovered / Resolved in April 2022 for the event had a little leg swelling and was Recovered / Resolved in April 2022 for the event baby had been non-stop crying/screaming ever since receiving the vaccines.
Headache, inj site pain, foggy head, headache, body aches, fatigue, skin sensitivity Narrative: day 1 - inj site pain, foggy head, headache, body ache; day 2 - body aches, fatigue, skin senstiity
Narrative:  VETERAN REPORTS LEFT SIDED FACE/MOUTH AND EYE TWITCHING STILL ALMOST 2 MONTHS AFTER J/J VACCINE. UNSURE IF RELATED TO ANXIETY OR VACCINE.
No adverse event; Given the monovalent vaccine as booster; This spontaneous case was reported by a patient family member or friend and describes the occurrence of WRONG PRODUCT ADMINISTERED (Given the monovalent vaccine as booster) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Given the monovalent vaccine as booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Given the monovalent vaccine as booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medications were reported.  Reporter stated that both she and her husband got the Moderna bivalent vaccine on 07-Sep-2022. Her husband just got back from his doctor and was told that this was not the bivalent that they got but the old one.  This case is for the husband.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-675027 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-675027:Wife case
Pt reports a red, swollen throat and some tightness in the chest; beginning a couple hours after vaccination. She reports no real difficulty breathing at this time. Advised to take some diphenhydramine and acetaminophen for symptoms, and to seek emergency medical attention if any irregular heart beat or difficulty breathing, and follow up with her physician.
Hives right arm, muscle soreness, fever, difficulty breathing, increased heart beat, weakness.
About 6-7 days after the second vaccine I began having palpitations, fluttering, pounding heart, increased SOB, chest tightness, severe fatigue, arm/leg tingling that seemed to increase in intensity and frequency over about 2-3 weeks, then chest pain that felt like I was having a heart attach on Thanksgiving Day (severe SOB, chest pain into my left jaw/neck/arm) and went to the ED.  Symptoms remain but less frequent and intense.
This spontaneous report has been received from nurse regarding multiple unspecified patients of unknown age and gender. The patients concurrent condition and medical history were not reported. On unspecified date in October 2015 ranging from 20-OCT-2015 to 28-OCT-2015 the patient was vaccinated with improperly GARDASIL 9 (lot # L016428, Expiry date: 30-JUL-2017) (strength, dose and frequency not reported). No adverse events were reported. This Case is one of 2 reports from the same reporter. Additional information has been requested.
Order given for Hepatitis A # 1 dose Merck & Co 0627AA.
This spontaneous report was received from a physician via a company representative reporting on unknown number of patients of unknown age and gender. Patient's pertinent medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with a dose of PNEUMOVAX23 (lot number, expiration date strength, dose and route were not provided). Concomitant medication was not reported. The physician reported that the facility, where he sited on at the unspecified facility where he had a surgery and was vaccinated with PNEUMOVAX23 (captured in MARRS#1511USA010027), had encountered, on an unspecified date, other patients with his same experience of pyrexia reported as "fever". The outcome of pyrexia was unknown at the time of the report. The reporter did not assess the relatedness of PNEUMOVAX23 to pyrexia. This is one of several reports from the same source. Additional information has been requested.
Patient developed discoloration- similar to cafe au lait spot over the injection site.  1x2cm. Mom estimates this occurs 2-4 weeks after. Not painful. Has not changed in 3 months since it developed. No other rashes or cafe au lait spots on body.
Red, inflamed rash to neck and portion of face; Red, inflamed rash to neck and portion of face; This is a spontaneous report from a contactable consumer (patient).   A 59-year-old (non-pregnant) female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6204, Expiration date: not reported) via an unspecified route of administration in Left arm on 04Mar2021 at 16:15 (age at vaccination: 59-year-old) as dose 2, single for COVID-19 immunization. Medical history included long term diagnosis with eczema and rosacea. Concomitant medications included spironolactone 25 mg, gabapentin 500 mg and melatonin (in two weeks). The patient past drug included Tylenol 3 and codeine and the patient had known allergies with Tylenol 3 and codeine. On 05Mar2021 at 16:00, (began within 24 hours of vaccination) patient experienced red, inflamed rash to neck and portion of face. No treatment was received for the events. The events was lasted just under 48 hours. The patient did not receive other vaccine in four weeks. No covid present prior vaccination. Covid was not tested post vaccination. The outcome of events was recovered on an unspecified date in Mar2021.  No follow up attempts are possible. No further information is expected.
Moderna COVID-19 Vaccine EUA  Skin reaction at site of injection.  Large red circle, slightly raised about 2" x 2.5" .  Does not itch.
rash; Injection site swelling; injection site red; This case was reported by a other health professional via sales rep and described the occurrence of injection site rash in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th April 2019, the patient received Shingrix. On 26th April 2019, 9 days after receiving Shingrix, the patient experienced injection site rash, injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site rash, injection site swelling and injection site erythema were unknown.   It was unknown if the reporter considered the injection site rash, injection site swelling and injection site erythema to be related to Shingrix.  Additional details were provided as follows: This case was reported by the Medical assistant (MA). The patient experienced rash, swelling and redness starting at injection site. On 29th April 2019, the patient was seen on office and did Immunoglobulin E test but it was low so not determined not an allergic reaction.
Narrative:  Covid +, COPD, SOB, dex, remdesivir, J&J, d/c home
She has picked up a cold in the last few days; This is a spontaneous report from a contactable consumer (Patient) or other non-health care professional reported for herself. An unspecified age female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for Covid019 immunization. She got her Pfizer shot and is due for second one tomorrow. She has picked up a cold in the last few days. She thinks it is a cold. She wonders if they will give it to her tomorrow. She is not sure if she should show up and infect everyone.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up
Persistent left axillary lymph node enlargement following SARS-CoV2 vaccine.
pt currently has muscle pain at the injection site, chills, and has pain on upper left leg in between knee and groin area. Pt had 101.2 fever the night after the injection but it subsided by morning.
Headache; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and MYALGIA (Body aches) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 848821A and 844A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced HEADACHE (Headache) and MYALGIA (Body aches). At the time of the report, HEADACHE (Headache) and MYALGIA (Body aches) outcome was unknown. Not Provided          No concomitant medication was reported. Treatment information not provided. Action taken with mRNA-1273 in response to the events was not applicable.