chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse effect reported; patient received improperly stored VARlVAX; This spontaneous report was received from a registered nurse and refers to a patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 23-AUG-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # R019237 with an expiration date on 04-JUL-2020 or lot # S005078 with an expiration date on 19-FEB-2021 (exact dose, injection site and route of administration were not provided) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (MERCK) injection (exact dose, injection site, route of administration, indication, lot # and expiration date were not provided). Administered dose experienced the temperature excursions of -14 degrees Celsius to -10 degrees Celsius (-9.74 degrees Celsius) (timeframe was not reported). The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. No adverse effects were reported.
This spontaneous report as received from an office manager refers to a unknown number of patients of unknown demographics. The patient's current conditions or medical history were not reported. On an unknown date, since December 2013, an unspecified number of patients had been administered PROQUAD (Merck) (dose, route, lot number and expiration date were not reported) and TD that had been improperly stored. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Clinical varicella (mild) < 50 lesions, mild tactile fever. Vaccine given 1997, DX varicella 2005.
vaccination site inflammation; swelling lips; soreness; rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INFLAMMATION (vaccination site inflammation), LIP SWELLING (swelling lips), PAIN (soreness) and RASH (rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Shellfish allergy.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE INFLAMMATION (vaccination site inflammation), LIP SWELLING (swelling lips), PAIN (soreness) and RASH (rash). At the time of the report, VACCINATION SITE INFLAMMATION (vaccination site inflammation), LIP SWELLING (swelling lips), PAIN (soreness) and RASH (rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medication was reported.   Reporter did not allow further contact
Very sore arm after first dose, lasted five days; Swelling of my shoulder after first dose, lasted five days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Very sore arm after first dose, lasted five days) and PERIPHERAL SWELLING (Swelling of my shoulder after first dose, lasted five days) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 28A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure and Cholesterol.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Very sore arm after first dose, lasted five days) and PERIPHERAL SWELLING (Swelling of my shoulder after first dose, lasted five days). At the time of the report, PAIN IN EXTREMITY (Very sore arm after first dose, lasted five days) and PERIPHERAL SWELLING (Swelling of my shoulder after first dose, lasted five days) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-103779 (Patient Link).
Redness, itching at injection site; severe itching (no rash) on face, scalp, neck & arms starting 1-2 days after vaccination - lasted about 10 days. Rash on chest - 2 or 3 "pimples" after that - resolved in a few days. Exacerbation of pain in area of bone infection. Resolving after 2 weeks.
3hrs post vax pt developed hives on the arm not used for the inject; No further details were provided;
pt recv 2 doses of vax 1995 & diagnostic lab test indicated that the pt failed to seroconvert;
approx 3 days p/ vax pt exp varicella-like rash. pt was afebrile. addl info requested
I experienced fever, chills, night sweats starting the day after I received the vaccine lasting 24 hours.  I had a sore arm from my shoulder to my elbow, despite not feeling the injection.  My lymph nodes under my L arm were swollen for one week, and my lymph nodes in my neck were also swollen for several days.  I had a rash on my L lower neck/clavical area.  I also had a swollen L ear with welts, blisters, crusting over continuously for the past 12 days.
First vaccine ever received: Vomiting x2 on 1/14/20 @ 4:00am and 12pm. Malaise. Lethargy. Headache. Muscle weakness. Low grade fever (100.3). Resolved.
Child received Hep B and Fluzone on 9/25/2021. The same day developed rash, so parents took child to ER, was diagnosed: Nonspecific rash around mouth and trunk. Benadry (12.5mg/5ml) 7.875mg  was given in the ER
We live with our son and his wife and 2 kids. They tested positive for Covid. I got tested since we live in the same house. I tested positive too. I did not have any symptoms. I only felt a little fatigued and had a little bit of cough. I got the antibodies a couple of days later. It went away probably in 3 days after getting the antibodies. Then I tested negative after 10 days.
GlaxoSmithKline - FLUARIX given 9/27/12 (Thurs. afternoon). Woke up Friday morning with rash to back, extremities, groin area. No difficulty breathing, rash and itching. Seen in Urgent Care on 10/1/12, given Medrol 4 mg pak x 6 days and will f/u with PMD.
Information has received from a licensed practical nurse concerning a female who was vaccinated IM with a dose of Gardasil. It was reported that the patient may have received more than one other unspecified vaccination. Subsequently, the patient fainted. The did not seek medical attention. The patient outcome was unknown. This is one of three reports from the same source. Additional information is not expected.
Started twitching under my eye/cheek area about 2 hours after. Tips of toes are numb and feet are tingly. Heart felt weird?
Severe headache x 36-48 hrs. (migraine- like- acute onset 12 hrs after vaccine- awoke pt from sleep)
approx. 3 hours post injection patient woke with whole body pruritis, MD paged, topical benedryl ordered for itching. Lotion applied, awaiting results.
Patient experienced pain and rash on the arm from the shoulder to the elbow. It started on 10/07 at night. On 10/10, the patient came to reported and she said that it is getting better. Advice her to take Ibuprofen and Benadryl and let her PCP know.
This spontaneous report as received from a physician and a registered nurse refers to a 69 year old male patient with none pertinent medical history. On 10-OCT-2014 the patient was vaccinated with ZOSTAVAX (Lot number, dose and route not reported). Concomitant vaccinations included Influenza virus vaccine (unspecified) administered on 08-OCT-2014, two days prior to the administration of the ZOSTAVAX (also reported as none concomitant medications). On 15-OCT-2014, 5 days after onset of therapy the patient developed a rash from the groin to the knee. None lab diagnosis studies were performed. The patient received cortisone cream and antihistamine. The physician report that the event improved within 24 hours and the patient was recovered. There was no reintroduction due to this being a vaccine. The patient sought unspecified medical attention. Additional information has been requested.
APPROXIMATELY 4 PM PT RECEIVED VACCINE, WITHIN 10 MINUTES, PT HAD NAUSEA, DIZZINESS AND EXTREME NUMBNESS AND WEAKNESS, IN BOTH LEGS AND ARMS (MORESO IN LEGS). PT WAS EVALUATED AND EXHIBITED ROTARY NYSTAGMUS, AND WAS UNSTEADY WITH MOVEMENTS. SHE HAD DECREASED MUSCLE STRENGTH. SHE WAS SENT TO ER FOR EXAMINATION.
Fever at 7am at 2/20. Fever is 102.2. Extreme fatigue, sore muscles.  Hard to walk and keep balance. Dry mouth. Head ache. Numbness in arms
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, concomitant therapies and drug reactions or allergies provided. On an unknown date, the patient was vaccinated with an improperly stored dose of Oka-Merck PROQUAD subcutaneously, lot # R001541, 15-JUL-2019 (dose was not reported). It was unknown, if sterile diluent (strength, dose, lot# and expiration date were not reported) used to reconstitute was stored properly. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion from 6 degrees Fahrenheit to 14 degrees Fahrenheit for 43 minutes. There was no previous temperature excursion. Information was received from a data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1807USA010837.
Within about an hour after receiving her flu shot at work, pt felt like something was in her throat that she couldn't swallow - went to ER - treated with IV SOLUMEDROL, BENADRYL, albuterol neb.
Local reaction at injection site. Upper right arm is swollen, hot and itching. Pt took 1/2 tab of 10 mg loratadine and itching stopped. Dr said that it is just local reaction and suggested to take BENADRYL tablet and to use ice pack to cool down.
She lost head control and her head would only turn to the right. She wouldn't move her head left anymore it was stiff right.
Woke up the morning of 10/2/2020 (day following vaccines) with rash on body.  Rash improved with Benadryl.  Mother did not contact office until 10/8/2020.  Had been having rash daily since then.  Seen in our office.  The rash was a mix of urticaria and erythema multiforme type lesions.  It was on her upper arms, back, chest, abdomen, buttocks, upper legs.  She had no other findings.
The vaccine dose was administered 8 days early. This was the 4th covid vaccine given in the series.
About 8 hours after the injection I felt nauseous and had diarrhea. I had chills, body was sore and achy. Headache That lasted about a day or 2. 2 days after the vaccine I had chest pain for 4 days. It was worse at night and made it difficult to sleep. I have also been having disrupted menstrual periods since my first vaccine in March 2021. My periods come about every 2 weeks now and last only a couple days. Sometimes they are normal but other times I have missed my periods. This has been going on for several months and has never happened before getting the Covid-19 vaccine. It seems to be getting more irregular over time, as I keep having to get boosters.
12 pm: Time of vaccination. 6 pm - 12 am: Onset and gradually increasing chills. 12 am - 3 am: In addition to continuing chills, heartbeats per second was approximately in the 2.5 to 3 range. Fell asleep shortly after midnight.  3 am: Awakened with sweating and ongoing rapid heartbeat. Burning heart sensation. 3:11 am: Heartbeat began decreasing.  3:41 am: Heartbeats per second in the 2 to 2.5 range. 4 am: Heart issues subsiding, but still uncomfortable. Throbbing pain in head like someone hitting the back of head with lumber. 6:25 am: Heartbeats per second still above 2. Throbbing pain in head continues. Stabbing sensation in heart. 8:12 am: Out of bed. Issues lessening, but throbbing head pain continues.  One week later 1/5/2022: Continued soreness/tightness in heart.
Symptoms began to appear the following morning starting with a sore throat. General tiredness and lethargy progressed throughout the day. Symptoms peaked that night (9/04) with a fever of 101.5 degrees Fahrenheit at approximately 11 PM, extreme tiredness, headache, and mild nausea. Over-the-counter medications such as NightQuil were taken to alleviate symptoms. The next two days had symptoms lessened to coughs and stuffed/runny nose.
left sided  non positional chest pain.  seen in ER .  Was treated with Toradol  and resolved.  Negative work up  in emergency room. for cardiogenic or pulmonary causes.
Arm pain getting worse; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain getting worse) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm pain getting worse). At the time of the report, PAIN IN EXTREMITY (Arm pain getting worse) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter
This spontaneous report was received from a pharmacist refers to a 65 year old male patient (also a physician) with no drug allergies. The patient's medical history included shingles. On 08-MAR-2008 (about 5 years ago), the patient was vaccinated with a dose of ZOSTAVAX (lot # not reported), 0.65 ml, subcutaneously in the right arm. Patient is on Medicare par B. On 10-MAR-2013, the patient experienced shingles again. The reaction was on the dermatome on the back. Patient received acyclovir as treatment for 10 days. The patient stated to the pharmacist that the shingles was not severe as the case as before. Patient sought medical attention (saw an unspecified physician). No laboratory tests were performed. The outcome of shingles was reported as recovering. Causality was not provided. Additional information has been requested.
p/vax pt started behavior problems, sleeping patterns; immed p/vax temp wnet up; was given Panadol & sponge bathes to bring temp dec; mom did not take temp;
chills, t102, muscle aches, nausea, loss of appetite, sore throat; pt's daughter was dx w/strep throat 2 wks ago;
pt recvd Hep B vax on 26FEB92  & w/in 24 hrs devel dramatic flare-up of urticarial reactions which covered entire body; lesions were assoc w/intense itching; No further details were provided;
diarrhea on the third day; When given the shot, a sensation ran up the left side of my neck; my arm hurt; felt ill within an hour; achy; headache; fatigue; increased blood pressure; felt unwell and had a headache for three days; This is a spontaneous report from a contactable consumer reporting for herself. A 59-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EN6200; Expiration date was not reported), via an unspecified route of administration in arm left on 26Feb2021 at 09:15 (at the age of 59-years-old) as dose 1, single for COVID-19 immunisation at hospital. Medical history included type 2 diabetes mellitus (MODY diabetic, 40 years), blood cholesterol (medicated for cholesterol), hypothyroidism (underactive thyroid) from an unknown date and unknown if ongoing. Concomitant medications in two weeks included glimepiride (GLIMEPIRIDE), metformin (METFORMIN) taken for type 2 diabetes mellitus; levothyroxine (LEVOTHYROXINE) taken for hypothyroidism; atorvastatin (ATORVASTATIN) taken for blood cholesterol, start and stop date were not reported. The patient previously took codeine and experienced drug hypersensitivity (known allergies: codeine). Patient had no other vaccine in four weeks. Patient had COVID prior vaccination and not tested for covid post vaccination. The patient experienced when given the shot, a sensation ran up the left side of her neck, arm hurt, felt ill within an hour, achy, headache, fatigue, increased blood pressure, felt unwell and had a headache for three days on 26Feb2021 at 10:00, diarrhea on the third day on 28Feb2021. The patient underwent lab tests and procedures which included mild COVID-19- tested positive on 10Dec2020; blood pressure measurement: 155/86, which is high for patient on 26Feb2021. When given the shot, a sensation ran up the left side of her neck. The sensation lasted all day; patient arm hurt and felt ill within an hour; achy, headache, fatigue; increased blood pressure (155/86, which is high for patient); felt unwell and had a headache for three days; diarrhea on the third day. No treatment was received. Clinical outcome of the event fatigue was recovered on 28Feb2021 and all other events were recovered on unspecified date in 2021.  No follow-up attempts are possible. No further information is expected
Had injection of MMR at pprox 2:30 PM Five minutes post injection felt dizzy and light headed and like she was going to faint. In ER she felt a tingling sensation over entire body and dryness in mouth, burning in stomach. She received Benadryl 50 mg IV, Solumedrol 125mg IV, and Pepcid 20 mg IV.  ASt 4:44p resting still feeling weak and light headed when attemps to raise her head. Monitor NSR. 156/76/76-20  97>9  o2 sat 100%
within an hour of being vaccinated, I developed a tremor in my left hand and arm that would not go away for 24 hours. Additionally, I developed a fever that lasted for 4 days, extreme fatigue, chills, and headache
The day after the vaccination, I woke up and had a headache, was nauseated, very fatigued and weak. I had a televisit with Physician Assistant on the night of 5-07-21. They told me to rest, drink fluids and if "you get any worse, just call us back". Symptoms lasted 4-5 days. I recovered after the 5th day.
pain, redness (4-5" oval), swelling, induration at injection sight, still present at 24 hrs
POTENTIAL MEDICATION ERROR (3 SHOTS GIVEN FROM AN EXPIRED PUNCTURED VIAL THAT WAS LEFT AT ROOM TEMPERATURE FOR MORE THAN 2 HOURS); INCORRECT STORAGE OF DRUG/ VIAL WAS STORED AT ROOM TEMPERATURE FOR MORE THAN 2 HOURS; EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced potential medication error (3 shots given from an expired punctured vial that was left at room temperature for more than 2 hours), incorrect storage of drug/ vial was stored at room temperature for more than 2 hours, and expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the potential medication error (3 shots given from an expired punctured vial that was left at room temperature for more than 2 hours), incorrect storage of drug/ vial was stored at room temperature for more than 2 hours and expired vaccine administered was not reported. This report was non-serious.
Co. Health Unit came to processing plant on 10/19/99, due to an outbreak of Rubella. Pt.had numbness in arm. Was seen on 10/29/99 and still had numbness in arm; feels like a stroke.
Pt stated that when he recieved his flu shot in October, about 20 minutes after injection he found himself "stumbling to the nurses office  fealing faint and dizzy). He stated he still wanted to proceed with Pfizer dose today. Injection given at 1030. At 1047 he notified staff of feeling faint and dizzy. Skin became pale. This RN and staff assisted pt to the floor and elevated feet on a chair. Pt remains awake and alert. VS: temp 98.2, pulse 60, BP 112/92, O2 98%, respirations 16. Pules 3+ bilaterally, cap refill WNL. After several minutes pt states he is feeling better. This RN assisted pt back to sitting position. He tolderated sips of water. Denies N/V. Pt waited with staff another 15 minutes before leaving. Educated pt to be evaluated at ER should symptoms re appear. Pt and wife verbalize understanding. Pt left facility at 11:05. Able to walk with out assisstance or dizziness. Called pt at 16:30 to follow up, states he is feeling fine and no further issues.
Vaccinated and boosted for shingles 3 years ago, got shingles now/suspected vaccination failure; Shingles on face (awful); Covid-19; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis, COVID-19 VACCINE for prophylaxis, COVID-19 VACCINE for prophylaxis and COVID-19 VACCINE for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine, the 1st dose of Shingles vaccine, the 3rd dose of COVID-19 VACCINE, the 2nd dose of COVID-19 VACCINE and the 1st dose of COVID-19 VACCINE. On an unknown date, more than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria medically significant), shingles and covid-19. On an unknown date, the outcome of the vaccination failure, shingles and covid-19 were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and covid-19 to be related to Shingles vaccine and Shingles vaccine.     Additional Information: Receipt Date: 12-SEP-2022. Reporter's Comment: This case was reported by a patient via  interactive digital media. The patient was vaccinated with shingles vaccine and boosted for shingles three years ago and he/she got shingles now in his/her right side of face, awful. The patient stated that, was also vaccinated twice and boosted once for covid-19 and experienced covid. On an unknown date, unknown after receiving covid-19 vaccination the patient experienced shingles and covid-19.  The patient asked if the vaccines really work? The patient was not so sure about it now. It was unknown if the reporter considered the shingles and covid 19 to be related to covid 19 vaccine.  Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The event covid 19 and suspect covid 19 vaccine was coded conservatively. The follow up would not possible as no contact details were available.
No adverse effects reported; One patient received one dose of improperly stored ROTATEQ; Information has been received from the office manager regarding a patient of unknown age and gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 29-JUL-2019, the patient received one dose of improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) for prophylaxis, lot number R025713 with expiration date on 20-JUN-2020 (strength not reported)  The rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was stored at a temperature range of 33.9 degrees Fahrenheit (°F) for the time frame of 20 minutes. The previous temperature excursion was 30.3 °F for 93 hours and 50 minutes. Other previous excursions were reported: lowest temperature below 36 °F (30.3 °F) for 90 hours and 7 minutes, another temperature below 36 °F (30.5 °F) for 1 hour 45 minutes and other temperature below 36 °F (35.2 °F) for 2 hours and 5 minutes. The most recent temperature was below 36 °F (33.9 °F) for the time frame of 40 minutes.  The call was because of a data logger.   No adverse effects reported.