chrisvoncsefalvay/vaers-outcomes huggingface dataset:
was cold; had chills; joint pain; had a little headache; just slept a lot; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (was cold), FATIGUE (just slept a lot), CHILLS (had chills), ARTHRALGIA (joint pain) and HEADACHE (had a little headache) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included LOSARTAN for Hypertension, VITAMINS NOS for an unknown indication.   On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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) at an unspecified dose. On 03-Mar-2021, the patient experienced FATIGUE (just slept a lot). On 04-Mar-2021, the patient experienced NASOPHARYNGITIS (was cold), CHILLS (had chills), ARTHRALGIA (joint pain) and HEADACHE (had a little headache). At the time of the report, NASOPHARYNGITIS (was cold), FATIGUE (just slept a lot), CHILLS (had chills), ARTHRALGIA (joint pain) and HEADACHE (had a little headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Body temperature: 98.3 (normal) normal and 95 (Low) decreased.         No treatment medications were provided.  Action taken with mRNA-123 is not applicable.
Information has been received from a pharmacist and a patient safety manager concerning a 6 year old female who at 10:45 a.m., on 26-JUN-2008 was vaccinated with a dose of ZOSTAVAX vaccine (Oka/Merck). The patient had been seen since then by her primary care physician on 27-JUN-2008 and 01-JUL-2008. She was fine with no adverse experiences. She was scheduled for VARIVAX vaccine (Oka/Merck) in 6 months. The patient safety manager felt this was a case of human error. Both vaccines are stored in the same freezer, though on separate shelves. They do a large volume of vaccinations and can be quite busy. The patient safety manager's senior management has issued an alert to other military bases to be careful to avoid such incidences. They have since placed "high alert" tags on the vaccines to remind the staff to be careful not to confuse ZOSTAVAX vaccine (Oka/Merck) and VARIVAX vaccine (Oka/Merck). This is one of several reports form the same source. The patient's sibling was also vaccinated with a dose of ZOSTAVAX vaccine (Oka/Merck) instead of VARIVAX vaccine (Oka/Merck) (WAES0806USA08964). Additional information is not expected.
Pain and soreness in vaccination arm was immediate for the rest of the day. Started feeling achey and feverish at the end of the day towards nighttime and bedtime. Took a Tylenol before going to bed. Woke up at 6:00a.m. feeling achey and feverish again, more severe this time. Attempted to walk to get another Tylenol and take my temperature, vision blurred and was extremely cold, immediate nausea, felt like I was going to pass out. Shaking and chills. After drinking Gatorade, ginger ale and water and eating peanut butter toast, nausea settled. After a bit, experienced severe stomach cramps. Drank more ginger ale and Gatorade and took a Tylenol to relieve pain. After 30-45 minutes, pain relieved and I was able to go back to bed. Rest of the day experienced pounding headache and feverish and achey body. Experienced fever highest at 99.8 during the day. After 24 hours passed, feel 100% better and all symptoms and side effects relieved. Only thing sustaining is a little bit of pain and soreness in the arm.
Information has been received from a pharmacy technician and a licensed practical nurse concerning a female patient (age not reported) who on 29-NOV-2007 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot# 657626/1084U). The licensed practical nurse reported that the patient was vaccinated at the same time in the same arm with a flu vaccine (unspecified). On 30-NOV-2007, the patient called the office to report that she had warmth and redness at the injection site and her arm was very inflamed and hot. The pharmacy technician noted that "it seemed like more patients had this experience this year than patients who received the vaccine last year." The patient sought unspecified medical attention. At the time of the report, the patient had not recovered. Additional information has been requested.
On 5/30/21, patient woke up around 10.30 am and complained of severe headache in back of head (pain level 8-9/10). She was nauseous, unable to sit and even stand. She was getting rainbow circles in her vision. Rushed her to emergency to UCSF, drs ran various  blood tests and brain MRI but everything was normal. It was also found that Bipasha had high BP 149/61. The drs could not make out what happened and they discharged her later on after giving some IV fluids and some pain medicine.  On 5/31 and 6/1, at home, patient was seemingly okay.  On 6/2, Wednesday, patient developed headache again, same symptoms like on 5/30. We rushed her to Urgent care in Fremont and saw her pediatrician dr and a pediatric neurologist. Her BP was high then also 144/87. No cause could be found why. The pediatric neurologist was suggesting it is possible that some Inflammation could be causing the blood fluctuations. Orthostatic testing resulted in major fluctuations of BP.  Both neurologist and neurosurgeon have ruled out hydrocephalus. They are saying heart inflammation could be a cause.
Post vax, the pt developed vesicles in left Ts dermatome, from nipple to scapula area. Dx with herpes zoster and temperature of 100.
The patient received FLUAD in left arm first, followed by PNEUMOVAX in right arm. Seconds after the PNEUMOVAX, patient complained of severe dizziness to which I had him raise his legs and place them on a second chair. Then the patient complained of having difficulty breathing that kept worsening fast. I immediately asked my tech to call 911 and administered 1 dose of epinephrine. The epinephrine did not seem to help. The patient was taking fast and shallow breath. The ambulance arrived a few minutes later and transported the patient to the hospital. The patient did not have any swelling in his lips mouth or airways according to the hospitl staff. It was a severe allergic reaction that most likely exacerbated his COPD. The patient recovered and was set to be discharged the same day.
Postherpetic Neuralgia; Shingles rash; Pain; Shingles; Rash; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 08-MAR-2023, the patient received the 1st dose of Shingrix. On 12-MAR-2023, 4 days after receiving Shingrix, the patient experienced shingles (Verbatim: Shingles) and pain (Verbatim: Pain). In MAR-2023, the patient experienced rash (Verbatim: Rash). On an unknown date, the patient experienced post herpetic neuralgia (Verbatim: Postherpetic Neuralgia) and vesicular rash (Verbatim: Shingles rash). The outcome of the shingles was unknown and the outcome of the post herpetic neuralgia and pain were not resolved and the outcome of the vesicular rash and rash were resolved.   It was unknown if the reporter considered the shingles, post herpetic neuralgia, vesicular rash, pain and rash to be related to Shingrix.     It was unknown if the company considered the shingles, post herpetic neuralgia, vesicular rash, pain and rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 05-JUN-2023 The patient was self-reported this case. The patient reported that the she contacted GSK via web. The patient stated that she received first dose of Shingrix vaccine on Wednesday and experienced first symptoms of shingles on Sunday. The patient stated that it was just a coincidence. The patient first developed pain on sunday. Three months later, patient still in severe pain. On 14th March 2023 she went to the emergency room as she thought she had a heart attack. The patient was diagnosed with the shingles during the emergency room visit. The patient did not noticed she had rash until this time. The shingles rash had gone but the patient experiences post herpetic neuralgia. Patient wanted to know if she can receive second dose even though she suffering from post herpetic neuralgia. The reporter did consent to follow up.
This spontaneous case reported by a consumer, describes the occurrence of chest pain, dyspnea (some trouble breathing) and vaccination site pain (left injection site arm hurts) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The patient's past medical history included COVID-19 in November 2021. On Jan 26, 2022, patient received the first dose of mRNA-1273 (Moderna COVID-19  vaccine), unknown route; 1 dosage form. On Jan 26, 2022, patient experienced vaccination site pain (left injection site arm hurts). On Jan 27, 2022, patient experienced chest pain and dyspnea (some trouble breathing). At the time of the report, chest pain, dyspnea (some trouble breathing) and vaccination site pain (left injection site arm hurts): not resolved. Diagnostic results: November 2021, SARS-CoV-2 test: Positive. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. The patient received the vaccine in left arm shoulder deltoid muscle. It was reported as no cause determined. The patient has not received any treatment. The patient has not had any lab work or tests performed. Before receiving the Moderna COVID-19 vaccine, patient didn't experience any symptoms like this. The patient not hospitalized for COVID-19, and didn't receive treatment. Patient didn't have a history of myocarditis/pericarditis. Concomitant medications and treatment information not provided by reporter.
chills; fever; fatigue; body aches; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (fever), FATIGUE (fatigue) and MYALGIA (body aches) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma since 2000, Skin cancer, Latex allergy and Sulfonamide allergy. Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), MONTELUKAST SODIUM (SINGULAIR) and SALBUTAMOL SULFATE (VENTOLIN HFA) for Asthma, ESOMEPRAZOLE MAGNESIUM (NEXIUM CONTROL) for GERD, ATORVASTATIN for Hypercholesterolemia, LOSARTAN for Hypertension.   On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021 at 1:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Jan-2021, the patient experienced CHILLS (chills). 31-Jan-2021, the patient experienced PYREXIA (fever), FATIGUE (fatigue) and MYALGIA (body aches). The patient was treated with AZITHROMYCIN (ZITHROMAX) (oral) from 05-Jan-2021 to 08-Jan-2021 for SARS-CoV-2 infection, at a dose of 500 milligram. At the time of the report, CHILLS (chills), PYREXIA (fever), FATIGUE (fatigue) and MYALGIA (body aches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jan-2021, Body temperature: 100 (High) Body temperature-high. On 05-Jan-2021, SARS-CoV-2 test: positive (Positive) sars-cov2 rapid antigen-positive(nasopharyngeal sample).         Action taken with mRNA-1273 in response to the event was not applicable.       Reporter did not allow further contact
Patient came in for a Covid vaccine. She was registered into a clinic that did not have Pfizer. She was inadvertently given the Moderna vaccine since we did not realize she was 17. No side effects noted.
Her initial shot was 1/6/21. 7 days later tested positive for Covid through 2 rapid tests at the facility. They also sent 1 culture to the lab which confirmed positive on 1/18/21. I visited her on 1/18 and 1/20 and noticed something extremely wrong with her. She couldn't communicate. I called her PCP who immediately called the facility to rush her to the ER. Her Test results showed a small stroke on the front right lobe. She was hospitalized for about 10 days. She never regained her strength and her accomplishment in physical therapy of 125 feet, being reduced to never walking over 25 feet again. When her time was up, she transferred to a memory care unit. She just passed away 5/5/21.
Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered maintained activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Consulted with Public Health and Environment and did not recommend repeating this dose in question. No ill effect post administration was reported.
"Covid Arm" - a raised, red, itchy patch about the size of a half-dollar at the injection site (left upper arm). Symptoms were relatively mild, and went away over the course of 3-4 days.
10-15-2021: Woke up at 5 am with fever of 102, headache, chills, flu like muscle and joint pains.  Left arm was swollen and painful to move.  Swollen lumps in arm pit area and chest. Tightness in chest.  Took 2x500mg Tylenol every 4x6 hours to attempt to reduce fever and swelling.  Fever came and went over next 24 hours, all other symptoms persist 10-16-2021: Woke at 2 am, fever 102, headache, chills, flu like muscle and joint pains.  Left arm was swollen and painful to move.  Swollen lumps in arm pit area and chest. Tightness in chest. Spoke with Doctor through medical app, was told this was normal for side effect and would subside over the next 3 to 4 days.  Suggested I fill out a regulatory authority report.
This spontaneous report as received from a registered nurse and refers to a 4 patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies, drug reactions, allergies or pertinent medical histories provided. On unknown dates, the patients were vaccinated with 4 improperly stored doses of PROQUAD lot # M017334, expiration date 05-OCT-2017 (dose and route of administration were not reported). There were no adverse effects reported. Administered doses of vaccines experienced the temperature excursion between 15 and 46 degrees Fahrenheit (40F) for 15 hours. A digital data logger was involved. There were no previous temperature excursions reported. Product quality complaint was not involved. Additional information has been requested.
12 month old female with a history of breath-holding spells (normal CT. MRI and routine EEG) had a 5 minute generalized tonic clonic seizure after receiving the Varicella and Influenza vaccine oxygen saturation level remained >98% no anti-epileptic meds given. She was transferred to the ED and evaluated. She was not admitted to the hospital.
Diaherra, heavy chills and blurred vision, dizziness ever since the shot.
a flare-up of cold sores; herpes skin flare-ups; This is a spontaneous report from a contactable consumer (patient). A 23-year-old female patient received second doe of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 10Feb2021 (Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. Medical history included oral herpes from an unknown date (she had them in her childhood but none in like 10 years). The patient's concomitant medications were not reported. The patent previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Jan2021 (Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. A couple of weeks after on an unspecified date of 2021, the patient experienced a flare-up of cold sores and/or herpes skin flare-ups. The patient said she had them in her childhood but none in like 10 years. As a corrective measure her doctor put her on Valtrex for 30 days. The patient also reported that she saw a few articles talking about the Pfizer vaccine being a possible trigger for that. She commented: ' I thought I saw a study in a publication, Herpes Zoster following BNT162B2 COVID vaccine'. The outcome was reported as unknown for the reported events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medication use were not provided. In or around MAY 2017, the patient was vaccinated with ZOSTAVAX (dose, route of administration, site of administration and lot # were not provided) for its intended purpose: the prevention of shingles. Shortly thereafter, the patient suffered headaches and neuropathy in her hand and foot. As a direct and proximate result of the vaccine, the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of his (Conflicting information, as patient is reported as a female) condition. As a result of ZOSTAVAX vaccine, the patient sustained severe and permanent personal injuries. Further, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient incurred and will continue to incur medical expenses and other economic harm as a direct result of use of ZOSTAVAX. The reporter considered the events of headaches and neuropathy in her hand and foot to be related to ZOSTAVAX. Upon internal review, the event neuropathy in her hand and foot was determined to be medically significant. The events of headaches and neuropathy in her hand and foot were considered to be disabling. Additional information has been requested.
A 56-year-old with a history of recent stem cell transplant one month prior, had received a left deltoid injection of FLUZONE SV 2007-2008, lot number U2493AA, on 08 November 2007. Two days later, the patient developed mouth sores. Other medications included Ambien, Crestor, Diovan, metolazone, and Lasix. The event did not required examination by a physician. Recovery status was unknown.
NAUSEA, CHILLS, MALAISE, INJECTION SITE PAIN Narrative:
Right underarm lymph nodes swollen and is a large mass. It is still swollen. I noticed it on Sunday, 3-14. I received my first Covid shot on Friday, 3-12, and my underarm is still swollen today, 3-16-21.
From initial information received on 12/21/04 from the patient's niece regarding an adverse event occurring in the USA, it was reported that an 89 year old female patient received a dose of FLUZONE at 11:00 AM on 10/11/2004. The lot number, site and route of administration were not provided. Eight hours later, on 10/11/04 at 7:00 PM, the patient complained of dizziness and her hands were shaking. She was seen in an emergency room, was diagnosed with kidney failure and was admitted to the hospital on 10/11/04. The patient was seen by renal specialists, critical care physicians, neurologists and infectious disease. The patient was hospitalized until she died on 12/13/04. No autopsy was performed. Medical Records received on 1/07/2005 states pneumonia and respiratory failure.
Per mom "screaming cry" initially lasting 3 1/2 - 4 hours which started about 3 1/2 hours after receiving immunizations on 021306 Also temp. 100.9 degrees, denies rash or swelling or reddness doctor recommended warm compresses to injection sites. 2 hours of crying episodes continued for next several days & mom switched from Tylenol to Mortin & saw doctor 021606 & increased dose of Motrin & per mom resolved by 021806.
pain at the injection site; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (pain at the injection site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced INJECTION SITE PAIN (pain at the injection site). At the time of the report, INJECTION SITE PAIN (pain at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
A Spontaneous report has been received from a Health Professional concerning a 24 year old, Female patient, who had been receiving FLUMSIT quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started on an unknown date. It was reported that the patient describe expired FLUMIST quadrivalent administered which started on 18-Apr-2015. The outcome of the event of expired FLUMIST is unknown. The report was considered to be non-serious.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Dec2020 at 09:00 as dose 1, single (Batch/Lot number: unknown), in right arm and on 14Jan2021 at 08:00 as dose 2, single (Batch/Lot number: unknown) at the age of 39 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 20Nov2021 at 15:00 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Crohns disease" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Seasonal allergies" (unspecified if ongoing), notes: Seasonal allergies; "Interchange of vaccine products" (unspecified if ongoing), notes: Vaccine brand other: Moderna. Concomitant medication(s) included: SINGULAIR, start date: 01Mar2021, stop date: 01Mar2021; XYZAL, start date: 01Mar2021; LO LOESTRIN FE; ALLERGAN, start date: 25Mar2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Apr2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Apr2022) Almost negative, notes: had an almost negative rapid test on day 8 of COVID; (27Apr2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.