chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt received Tdap at clinic Sunday 9-2-2012. Pt called from school to report left upper arm swollen to size of tennis ball with fluid, red, warm and tender. Pt states she will see health provider today.
On the 31st I developed COVID.  Runny nose, back ache, and covid symptoms.  I still can't smell nor taste.
Sore arm from both shots. Slight headache after first shot. Contracted Covid19 (unknown if Delta variant) on Sept 6, 2021
Initial information received on 07-Jun-2018 regarding an unsolicited valid non-serious case received from a health care professional (office person, medical assistant). This case involves a patient (age not reported) who received an expired dose of ADACEL (batch number, expiration date, route and site of administration were not reported) on an unspecified date. It was actual medication error due to expired vaccine used. It was reported that ADACEL was kept at 58.5F for 6 hours "closed ok". "Open products discard explained says PPD covered her other products". It was not reported if the patient experienced any adverse event, following vaccination. Lab test and corrective treatment: not reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Patient received two previous doses of Pfizer on the following dates: 06/04/2021 and 06/25/2021. When asking the patient if they had ever received a Covid-19 vaccine previously, patient stated "no". Patient also marked "no" when filling out the consent form prior to receiving the vaccine.
Skin colored fine, sand papery, papular rash developed on patient's face, chest, abdomen, back arms, and legs the day following his first HAV immunization. No erythema, No prutitus.
pt recvd vax & had stomach cramps; fever; malaise ;saw MD at ER w/ c/o lethargy; cont to exp lethargy & migraine x 5days
1st dose we got may have been expired.; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1st dose we got may have been expired.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 028A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (1st dose we got may have been expired.). On 23-Jun-2021, EXPIRED PRODUCT ADMINISTERED (1st dose we got may have been expired.) had resolved.            No concomitant medication was reported.  No treatment information was reported.   This case was linked to MOD-2021-234082 (Patient Link).
lessen the resulting site pain; This case was reported by a other health professional via interactive digital media and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as an adult as per the vaccine indication. The patient received Shingrix and had injection site pain. The reporter asked if apply ice right after shot could lessen the resulting site pain.
Resident had body aches, a low O2 sat  and had chills starting on 12/30/20. He had stated that they had slightly improved. On 1/1/21 he sustained a fall with a diagnosis of a displaced hip fracture. On 1/2/21 during the NOC shift his O2 sat dropped again. He later went unresponsive and passed away.
Patient received a gardasil vaccine injection.  Appeared fine, walked to front office to check out.  Was speaking with the check-out person and without any warning fell to the floor.  She was unconscious briefly.  She hit her head on the floor and bit her lip.  She was given smelling salts and ice was placed on her lip.  She laid on the floor for about 20 minutes and was moved to an exam room where she was monitored for approximately 2 hours.  She called her father and he picked her up to take her home.
full on flu symptoms; muscle aches widespread; headache; chills; fever; This case was reported by a consumer via interactive digital media and described the occurrence of flu symptoms in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 12th April 2022, the patient received Shingles vaccine. In April 2022, less than a week after receiving Shingles vaccine, the patient experienced flu symptoms, muscle pain, headache, chills and fever. On an unknown date, the outcome of the flu symptoms, muscle pain, headache, chills and fever were unknown.   It was unknown if the reporter considered the flu symptoms, muscle pain, headache, chills and fever to be related to Shingles vaccine.  Additional Information: GSK Receipt Date: 13-APR-2022 Reporter's Comment: This case was reported by the patient via interactive digital media. The patient had got full on flu symptoms, muscle aches widespread, headache, chills and fever.  The patient honestly did not think that, he/she would feel like this. Hence, he/she was not getting booster. Additional Supportive Information: The follow up would not possible as no contact details were available.
After pt. was given 2 shots (PNEUMOVAX 23 and FLUAD) pt fell off chair while waiting 15 mins of observation. Pt. was pale and sweaty but very alert. RPh comfort and monitor pt. while another called 911. Pt. stated that this happened to him before but did not mark on immunization form. 5 hrs. later - assistant came by pt. home to check on him: reported back that he was doing well.
The pts husband called and stated theat his wife began complaining of swollen painful glands on back of neck and behind ears. The pt saw her MD, he was unsure why the pt was having symptoms.
Covid 19 I tested positive for covid on August 18, I experienced drainage in throat, congestion, I had a fever it got up to 105.0 had a cough with stuffy nose, I had to sleep sitting up otherwise i would cough all night. On Friday I was really lazy and tired and on Saturday i started to feel a little better. I was taking Paxlovid for my symptons as directed by my Dr 3 pills twice a day for 5 days. I was also taking Tylenol as well for pain.
Patient emailed 12/21 and described on set of annoying, cool tingling sensation of lower extremities that began last evening. Writer called patient to obtain more information about symptoms. States is experiencing an annoying, cool, tingling sensation in lower extremities that is hard to describe.  Reports it feels almost like it's asleep, but cool. The symptoms began in the lower extremities and is now into the hips. Says has had difficulty sleeping due to the symptoms. States is able to walk, and not experiencing any shortness of breath. Instructed to notify her provider right away or report to the Emergency Department for evaluation and treatment.
Patient developed a mild case of chickenpox. Pt consulted a dermatologist and was treated with hydroxyzine syrup for itching.
Patient's arm has been sore and tight for 4 weeks after the shot, he said he can hardly lift it up but no redness or bruising though.
swollen face/after 5 hours it started on right side of my face is swollen but its still the same; redness of my eye; eye still swollen; This is a spontaneous report from a contactable consumer (patient).  A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 19Apr2021 as dose 2, single for covid-19 immunization. The patient medical history was not reported. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 29Mar2021 as dose 1, single for covid-19 immunization. The patient's concomitant medications were not reported. On 19Apr2021 patient experienced swollen face because after that patient received second vaccine, after 5 hours it started on patients right side of the face, it was swollen but its still the same and patient does not had pain, the redness of patients eye disappeared on same day on 19Apr2021, but eye was still swollen on 19Apr2021. Outcome of events was not recovered for swollen face/after 5 hours it started on right side of my face is swollen but its still the same, eye still swollen and recovered on redness of my eye on 19Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient received Pfizer COVID vaccine on 3/21/21 and 4/11/21. On 10/24/21, patient admitted to our facility with acute hypoxemic respiratory failure due to a combination of COVID-19 pneumonia with likely secondary bacterial pneumonia (symptoms started on ~10/10/21). As of today (11/1/21), patient's hypoxia gradually improving and now transitioned off high flow oxygen to 6 L oxygen. CRP now normalized Chest x-ray showed bilateral airspace opacities consistent with COVID-19 pneumonia. Required BiPAP support on 10/25/21 and transferred to hospital, but now with overall stable respiratory course. Continue dexamethasone (day 9).  Received tocilizumab on 10/25/21. Was not a candidate for remdesivir, with initial symptom onset on 10/10.  Completed 5-day course of ceftriaxone/azithromycin to cover secondary bacterial pneumonia. Patient was in the med/surg unit 10/24-10/25, then CCU 10/25-10/26, then back to med/surg 10/26. As of today (11/1/21), patient is still in med/surg unit with anticipated discharge in 1-2 days.
On Wednesday, October 19th, patient received the oral rotavirus vaccine.  Immediately after the dose was given, patient nursed and then fell asleep.  Typically at this time of day he naps for about two hours. On this day he slept for six hours and woke suddenly.  He began screaming until he was dark red in the face. He drew his knees to belly and couldn't be soothed. He would not eat either. After 20 minutes of this behavior I gave him a full dose of Children's Tylenol. Another 40 minutes of this intense screaming past and he finally exhausted himself to sleep.  He slept for about an hour and woke very fussy and seemed uncomfortable. The fussiness and soft cries continued through the next evening. Throughout this period I continued to give him does of Tylenol.
Off label use; Rationale: The case is considered as invalid in the system core due to lack of valid adverse event. Based on reported information, it seems that the patient has shingles before receiving Shingrix. Also, symptoms persisted after Shingrix administration and diagnosed at the time of enquiry. Since Shingrix is intended for protection of Shingles and not as treatment, in this case the patient had no event but a current condition.
Fever, chills, muscle pain, injection site pain, fatigue, general malaise, muscle weakness, mild chest pain.  Most symptoms appeared around 10 hours after injection.  Rest, fluids, tylenol No improvement with those treatments
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. In 2012, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided), as prescribed and/or administered by a healthcare provided for the long-term prevention of shingles and/or zoster-related conditions. Subsequently, the patient was treated by health care providers for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient suffered and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the shingles was unknown. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
When I woke up the next morning, my equilibrium was off, I was so dizzy I could barely get out of bed, it lasted off and on for about a week. In that initial week my hair started falling out, it slowly started growing back over time.
Toes tingling on left foot less than 24 hours after vaccine.  3days later itching between toes on left foot.  Within one week had fungal infection between toes on left foot and extreme redness, swelling, and pain on bottom of both feet.  At same time, came down with ?covid tongue?- coating and sores on tongue. This went away about 10 days later but feet are still an issue a month later.
Patient walking to exit, felt dizzy , sat down in chair, when attempting to leave again, stated went to floor.
Despite receiving varicella vaccine 1/25/02, pt dev. shingles R arm 12/17/02. Seen 12/17/02 and 12/19/02 for shingles. Vesicles appeared on right hand and arm 12/17/2002. Do not know the time.
This spontaneous report as received from a nurse via field employee refers to herself who was a female patient of unknown age. Nurse reported that she was administered ZOSTAVAX (strength, lot #, dose, route were unspecified) on an unspecified date sometime this week in March 2014 for "age eligible". Nurse reported a local reaction "in the office" (where ZOSTAVAX was administered) at the injection site descried as a little knot, swollen and red. Nurse also reported that she experienced itching and tingling all over her body at an unspecified time "fairly soon" after being administered ZOSTAVAX. Nurse stated that she was still feeling some generalized itching and had a little redness around the injection site. Patient took a BENADRYL and a CLARITIN this morning (28-MAR-2014) as treatment. No lab diagnostics studies were performed. It was unspecified if patient had sought medical attention. The outcome was unknown. Additional information has been requested.
Myocarditis I think, it started yesterday. I had never felt that.  Pulse pain from my heart right side (middle of the chest) , not continuous , several times per minute.
5/9/03 Fever for 24 hours. Slight rash on foot; otherwise no symptoms. Playful 5/10/03; no more fever.
Chest tightness and difficulty taking deep breaths (but regular breathing was okay). Also had trouble swallowing- feeling inflammation but not that bad. That started at 2am on 5/6/2021. When she called us, I recommended she go to the emergency room but she said she didn't go because she is feeling okay but still having symptoms. She also has a fever starting in the morning of 5/6/2021.  She is also having muscular and arm pain that goes from the chest to the back.  Right now when I talked to her daughter on the phone to help translate and get this information 5/6/2021 at 7:46pm I strongly suggested she go to the emergency room again since she is having the chest/arm pain that is mostly on the left side as well as her other symptoms.
Initially, swelling / hardness within a few hours of the shot. The next morning, exhaustion, pain, swelling / hardness. The following day, today, (after lots of sleep), feverish, and the area around the shot was hot, swollen / hard, and painful. I removed the bandages, and saw that it had a large red rash as well. A few hours of a cold compress on the affected arm seems to have quieted it down some. The fever went away relatively quickly.
Pt received vaccine on 02/17/2021, stated she had some arm pain which resolved within 2 days. Then  on 02/21/2021 In the evening she began to have diarrhea and T. of 102.4. She took tylenol and  imodium diarrhea resolved and t, decreased to 99.4. Then today she began to feel ill again with cold  like symptoms such runny nose, chills, sinus , neck pain and headache took over the counter cold meds.  PHN advised patient to follow up with PCP at this time. Pt voiced understanding and states she had  contacted VSAFE as well. Spoke with patient again this evening stated she was feeling a little better and  had spoke with PCP and he said they would keep watching.
Patient was fine immediately after vaccine- about 2-3 minutes later she starting seizing, lost consciousness and fell over. It all lasted just a few minutes- she regained consciousness and was talking and upright by the time EMTs arrived. EMT arrived and assessed patient and she refused transport to hospital for further evaluation as she said this happens every time.
Patient walked up to the counter to state she felt funny and then fainted. She woke up within a minute and was gotten into a chair. She stood up to get something to drink and fainted again and revived soon after. 911 was called and they checked her out.
Patient presented her self to ER hospital. Rash at injection site. Some swelling at site.
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. The patient's current conditions and medical history were not reported. On unspecified dates, the patients were vaccinated with unspecified doses of improperly stored GARDASIL 9 (unknown strength and route). Concomitant medications were not reported. No adverse effect was reported. The outcome of the events was unknown. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Very dizzy, near black out, fatigue and dizzy all day on 10/07/2014.  Feel better on morning of 10/08/2014. Still some Vertigo effects. No treatment.  Sister had same symptoms.
Patient received both vaccines in one arm, new needle was used for each vaccine, alcohol pad was used to wipe skin clean by immunizer. Patient complained of redness and swelling within 12 hours of vaccinations. Skin was necrotizing within 12 hours of vaccination and infection occcurred. Patient had to get surgery to have top dermal layer of skin removed on 11/1/19.
his first shot, it hurt for about an hour and a half and it was more intense in the second shot; This is a spontaneous report from a contactable consumer or other non hcp (patient reported for himself) from a Pfizer sponsored program. A 66-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration on 01May2021 (at the age of 66-year-old) as dose 2, single for COVID-19 immunization. The patient medical history included, ongoing cervical stenosis, ongoing RA, ongoing COPD, ongoing emphysema. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration on 10Apr2021 (at the age of 66-year-old) as dose 1, single for COVID-19 immunization and experienced first shot it hurt. On an unspecified date in May2021, the patient experienced his first shot, it hurt for about an hour and a half and it was more intense in the second shot. Verbatim and Event Description: Patient had both doses of the vaccine last 10Apr2021 and 01May2021. Patient mentioned that he has some health issues like cervical stenosis, RA, COPD and emphysema. He mentioned that when he got his first shot, it hurt for about an hour and a half and it was more intense in the second shot. Patient called in to know and get some advice when to take the follow up shot or booster shot. Outcome of the event was unknown.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
Injection site soreness; arm soreness; tiredness; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8733), via an unspecified route of administration in the left arm on 30Mar2021 at 15:30 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Patient had no known allergies to medications, food, or other products. Concomitant medications included calcium carbonate, magnesium carbonate, magnesium trisilicate (TUMS) for an unknown indication from an unknown date. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 30Mar2021 at 16:00, the patient experienced injection site soreness, arm soreness and tiredness. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of injection site soreness, arm soreness and tiredness were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Just over 36 hrs. after receiving flu shot -> 100 degrees temp. with generalized aches, fatigue, and headache. Extreme exhaustion -> slept 16 hrs. straight on 11/16 -> into 11/17, 5AM woke up feeling ok. Used Ibuprofen for pain and fever. (3ts x 48+ hrs.). Reported to me 11/19/13.
headache; SHIVERING; This case was reported by a other health professional via sales rep and described the occurrence of headache in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number 7PG2M, expiry date 5th June 2022) for prophylaxis.   On 9th September 2020, the patient received Shingrix .5 ml. On 9th September 2020, less than a day after receiving Shingrix, the patient experienced shivering. In September 2020, the patient experienced headache. On an unknown date, the outcome of the headache was unknown and the outcome of the shivering was recovered/resolved.   It was unknown if the reporter considered the headache and shivering to be related to Shingrix.  Additional details were provided as follows: The patient received one dose of Shingrix on 9th september 2020 and experienced shivering later that night ,which was recovered next day  and headache. The reporter consented to follow up. No further information was available.
My daughter stopped having her period for 2 straight months after receiving her Pfizer Vaccine September 2021 and October 2021. Then  after not having her period for 2 months in a row it then resumed back to normal and now today 10/20/2022 she is  twenty days late for her period. My daughter only starting having issues with her period after receiving the Pfizer vaccine and  has always been right on time  each and every month: Pfizer Vaccines ( 2 doses) dates are 1st dose 8/17/2021 and 2nd dose 9/10/2021.