chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a other health professional via call center representative and described the occurrence of injection site swelling in a 4-year-old male patient who received INFANRIX (batch number 5N447, expiry date 23rd May 2019). On 27th June 2017, the patient received INFANRIX (intramuscular) .5 ml. In June 2017, less than a month after receiving INFANRIX, the patient experienced fever. On 29th June 2017, the patient experienced injection site swelling and injection site erythema. The patient was treated with BENADRYL and KEFLEX. On an unknown date, the outcome of the injection site swelling, injection site erythema and fever were unknown. The reporter considered the injection site swelling and injection site erythema to be almost certainly related to INFANRIX. It was unknown if the reporter considered the fever to be related to INFANRIX. Additional details were provided as follows: The patient received INFANRIX in left thigh. On 29th June 2017, the patient's mother called the office and noted that 2 days after vaccination with INFANRIX, the patient had an injection site reaction. The patient was seen in office and BENADRYL was prescribed. On 30th 2017, the patient's mother again called, and noted that 2 days after vaccination with INFANRIX, the patient had the injection site reaction was red, and doubled in size. In 2017, less than a month after receiving INFANRIX, the patient experienced fever. The patient required emergency room visit. The order for KEFLEX was prescribed.
pt recvd vax 8AUG95 sl to medium rash (red) covering most of body, elevated temp 99.2 as 10AUG95;pt up ad lib; cont w/ADL paper route etc;as of 330PM 10AUG95 per phone call of mom;mom did not take child to MD
2-3d after injection, developed leg and arm pains, arm weakness, vision blurring, loss of appetite dysphagia, overall feeling of unwellness. No difficulty walking, no numbness tingling. No gait changes. No difficulty breathing nor inability to swallow. These symptoms persisted for about 7 days, then were improved upon evaluation by me on 8-3-17. At evaluation she still had vision blurring, leg pains but arms were normal, dysphagia resolved; leg pains are improved. Pt does not appear to be Guillain Barre at this time, but she is 2 weeks out from the vaccine at this time.
8h post vax, violent shaking chills in torso only, with sensation of ice water in veins, lasting 2 hrs. 18 hrs post vax, significant fatigue lasting 24 hrs.  Thanks to everyone for their work.
This spontaneous report was received from a doctor in pharmacy concerning to a patient of unknown age and gender. On 07-JUN-2007, the patient was vaccinated with the first dose of GARDASIL (dose, route and lot reported). On 21-AUG-2012, the patient was vaccinated with the second dose of GARDASIL (dose, route and lot not reported). On 07-NOV-2012, the patient was vaccinated with the third dose of GARDASIL (dose, route and lot not reported). No other co-suspects were reported. No concomitant medications were reported. The patient received a compressed schedule for GARDASIL. No adverse effect reported. The outcome of the event was unknown. Additional information has been requested.
Nervous Anxiety; This is a spontaneous report from a contactable consumer (patient). A 77-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported PFIZER BIONTECH COVID-19 VACCINE; lot number: EL9265; expiration date: unknown) at vaccination age of 77-year-old via an unspecified route of administration in the left arm on 27Jan2021 13:30 at a single dose for covid-19 immunization. The patient's medical history concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior vaccination. The patient previously took naproxen (ALEVE) but had allergies to Aleve. The patient reported that she had nervous anxiety for second day (28Jan2021). The event did not receive treatment. The patient has not been tested for COVID-19 since vaccination. The outcome of the event was not recovered.
Pediarix given out of series, extra dosage; This non-serious case was reported by a other health professional via other manufacturer and described the occurrence of extra dose administered in a patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Previously administered products included pediarix (received pediarix series on an unknown date).   On an unknown date, the patient received Pediarix. On an unknown date, an unknown time after receiving Pediarix, the patient experienced extra dose administered (Verbatim: Pediarix given out of series, extra dosage). The outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 04-MAY-2023 The reporter was contacted in regard to Pediarix, with reporting a injection that was given out of series. There were given an extra dosage The patient received an extra dosage of Pediarix, which led to Extra dose administered.   The reporter was consented to follow up
leg aches, chills, joint pain, malaise started on 3rd day after injection.  Today is day 8 after injection & still have malaise and nausea. Had headache yesterday and day before. Also woke up at 3AM yesterday and day before in a cold sweat. Some leg ache today as well. Have been taking 2 extra strength Tylenol every 6 hrs which sometimes gives relief but not always.
muscle twitching (fasciculations) all over body 3 days after receiving the tetanus-diphtheria vaccine
No adverse effects; improperly stored M-M-R II; expired M-M-R II; This spontaneous report was received from a medical assistant, referring to a 28 year old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions and concomitant medications.   On 14-MAY-2019, the patient received an improperly stored and expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), in left arm, lot # N013868 (expiration date: 04-MAY-2019), for prophylaxis (strength, dose, frequency, route of administration was not reported). Other suspect therapy included sterile diluent (STERILE DILUENT), lot #M037021 (expiration date:04-MAY-2019) for prophylaxis (strength, dose, frequency, route of administration was not reported). Temperature excursion was above 47°F (52.7 F, multiple) for 35 min, as recorded by a data logger. No adverse effects were reported.
Case number PHEH2013US025053 is an initial spontaneous report received from a pharmacist on 27 Nov 2013. This case refers to a 17-year-old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with FLUCELVAX (batch number: 00923031A and expiry date: Jun 2014) at dose of 0.5 Ml intramuscularly on 26 Nov 2013. No adverse event was reported following this administration error. Following an internal review on 18 Aug 2014, a significant correction was done for the information received on 27 Nov 2013: The BPI labeling of the event "Inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population.
This spontaneous report was received from a 56-year-old female patient, who was also a pharmacist and was reporting on herself. The patient's current conditions included arthritis and allergy to celecoxib (CELEBREX). On an unknown date in September 2014, the patient was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX vial 19400 plaque-forming units (PFU) (lot # and expiry date were not reported) as a prevention against shingles. Concomitant therapies included diclofenac, zolpidem tartrate (AMBIEN), pramipexole dihydrochloride (MIRAPEX) and losartan potassium (+) hydrochlorothiazide (HYZAAR). On 08-OCT-2016, the patient developed some blisters across her backside and "things that wanted to be blisters" below her left knee down her calf and across her foot between her big toe and a second toe. On 11-OCT-2016, the patient was seen by her physician and an unspecified treatment was given for the event. No lab diagnostics studies were performed. On approximately 19-NOV-2016 (reported as "within six weeks"), the patient recovered from the blisters, but occasionally she still developed numbness between her left foot big toe and a second toe since an unknown date. The relatedness between the events and ZOSTAVAX was not reported. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA011716:
I received the Pfizer vaccine on the 14th of September at University. My arm was sore but that was normal symptoms however I ended up with a mild reaction to the injection site being swollen, redness, itchy, and feels like a lump is in my arm has not gone down since.  - I have been icing my arm however it does not seem to help. I tried to call VAERS and was told I needed to report online.
Sore arm; This is a spontaneous report from a contactable consumer (patient). An adult female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 21Jun2021 (unknown age at time of vaccination) as single dose for COVID-19 immunisation. The patient's medical history included ongoing underweight. Concomitant medications were not reported. Concern: the patient stated, her concern is not really addressed in any of the option when she called and she is not getting any answer from the CDC. This is what happened, she got first COVID shot (on 21Jun2021) and "they used a little tiny needle, that was very short" and she did get a sore arm, about 6 hours later. 3 weeks later exactly (on 12Jul2021), she got her second shot and "they used a regular sized needle". The patient is an adult woman that weighs about 90 pounds. She is very underweight. Her concern is the first shot, because the needle was so short, "did I get the correct amount vaccine?" The patient confirmed the vaccine as COVID 19 Pfizer vaccine. The outcome of the event was unknown.  Follow-up attempts have been completed and no further information is expected. The lot/batch number is not available despite the follow-up attempts made.
I was not observed after the shot. About 7 minutes later I got a sudden and severe itch on my left lower jaw with a bright red rash, my left nostril felt like ants crawling over it, the rash then spread a lighter red up my cheeks, over my chin, and to the right side of my face. Once it spread the itch went away, the itch lasted about 7 minutes. The rash then turned brighter and no longer spread, the brightest spots were along my jawline and followed a line to the other side of my jaw and was very dense (it looked like a severe sunburn) the rash on my cheeks and chin were not as bright (it looked like I got slapped repeatedly on both cheeks) it also showed what appeared to be spider veins on my cheeks that were bright red. We were stuck in traffic and couldn?t get to ER the rash lasted an hour and complete disappeared,  it left a numb internal feeling on my right cheek, I took a Benadryl and this feeling went away in 5 minutes.
Extreme soreness in my shoulder blades; Felt ill I had don an extreme workout; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shoulder blade pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced shoulder blade pain (Verbatim: Extreme soreness in my shoulder blades) and unwell (Verbatim: Felt ill I had don an extreme workout). The outcome of the shoulder blade pain and unwell were not reported.   It was unknown if the reporter considered the shoulder blade pain and unwell to be related to Shingles vaccine.     It was unknown if the company considered the shoulder blade pain and unwell to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 17-MAR-2023 This case was reported by a patient via interactive digital media. The patient got 2nd shingles vaccine and cause extreme soreness in her/his shoulder blades felt ill. The patient had done an extreme workout with weights. The patient was very happy he/she did get it The follow-up could not be possible as no contact details were available.
rash on right arm near injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash on right arm near injection site) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 026L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced VACCINATION SITE RASH (rash on right arm near injection site). The patient was treated with CORTISONE ACETATE (CORTISONE [CORTISONE ACETATE]) for Rash, at a dose of 1 dosage form. At the time of the report, VACCINATION SITE RASH (rash on right arm near injection site) had not resolved.            No concomitant medications were reported   This case was linked to MOD-2021-222960 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Follow up was received does not contains any new information On 06-Aug-2021: Follow up received 06-Aug-2021, and  Event outcome updated
Expired vaccine is stored and then administered; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Expired vaccine is stored and then administered) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vaccine is stored and then administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Expired vaccine is stored and then administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  On 29-Oct-2021, the vial was placed in the refrigerator. The vial did not undergo any temperature excursion and the patient had no adverse event.  The reporter also said that there was a confusion between the expiration date printed in the carton and the expiration date when the QR code was scanned.  No treatment information was provided.   This case was linked to MOD-2022-491837 (Patient Link).
Gout; This spontaneous case was reported by a consumer and describes the occurrence of GOUT (Gout) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced GOUT (Gout). The patient was treated with PREDNISONE ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, GOUT (Gout) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
On 2/24/12 she reported she had developed itchy hives on arms & hips 2 days after receiving YF VAX & 2" red, sore area at site of YF VAX. Sx's lasted 5 days. No breathing difficulty. Hives were scattered. Took 1/2 BENADRYL during day & full dose at HS x3. No sx's today (2/24/12). Denies had fever.
It was reported that "four hours, post vax, the employee experienced difficulty in breathing. She went to the ER where she was seen and prescribed treatment with prednisone, Ventolin and an inhaler. She responded in 30 minutes to treatment. Employee experienced about 2 hours of a croupy cough during 1998 following her Influenza vaccine. No medical attention was sought." Pt has completely recovered. "Reviewed, no additional information at this time, 11/22/99.  Follow up on 10/28/2002: "Upon internal review of all files, it was deemed necessary to amend the report by updating the Adverse Event coding by adding (added croupy cough, deleted allergic reaction).  This case was upgraded to a 15-Day Alert report due to it being medically significant/SAE and unlabled.  The patients previous adverse event experience from 1998 influenza vaccination was added to box 21 of the VAERS form.  This case is closed."
Arm sore at the vaccination site; Intense soreness and stiffness around neck/ shoulder blade; Intense soreness and stiffness around neck/ shoulder blade; Intense soreness and stiffness around neck/ shoulder blade; neck stiffness / intense soreness and stiffness around neck/shoulder blade; This is a spontaneous report received from a contactable consumer (patient). A 25-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 23Mar2021 at 11:45 (at the age of 25-years-old), as a single dose for COVID-19 immunisation. Medical history included Sulfa allergy from an unknown date. Concomitant medications included ethinylestradiol, levonorgestrel (LEVORA) taken for an unspecified indication, start and stop date were not reported.  The patient experienced neck stiffness / intense soreness and stiffness around neck/shoulder blade on 23Mar2021, at 11:45 with outcome of not recovered, arm sore at the vaccination site  on 02Apr2021, at 07:00 with outcome of not recovered. Details were as follows: On 23Mar2021, when receiving the vaccine, the patient experienced neck stiffness. The day after the vaccine, the patient no longer had any arm soreness or neck stiffness. On 02Apr2021 at 07:00, 9 days after the vaccination, the patient experienced arm sore at the vaccination site, intense soreness and stiffness around neck/ shoulder blade. The events did not result in doctor 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 neck stiffness / intense soreness and stiffness around neck/shoulder blade and arm sore at the vaccination site was not recovered.  No follow-up attempts are needed. No further information is expected.
red raised rash around injection site, swollen, itchy, hot to the touch, accompanied by headache
Chills; Arm Soreness; Hard bump; Swollen bump; Bump that was hot to the touch; Headache; This case was reported by a pharmacist via call center representative and described the occurrence of induration in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number 54H72, expiry date 1st October 2021) for prophylaxis.   On 8th November 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 11th November 2019, 3 days after receiving Shingrix, the patient experienced induration, swelling, skin warm and headache. On an unknown date, the patient experienced chills and pain in arm. On 11th November 2019, the outcome of the induration, swelling, skin warm and headache were resolved with sequelae. On an unknown date, the outcome of the chills was resolved with sequelae and the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the induration, swelling, skin warm, headache, chills and pain in arm to be related to Shingrix.  Additional details were received as follows: The reporter stated that patient had side effects following the second dose of Shingrix. The patient had a hard, swollen bump that was hot to the touch and a headache for approximately 2 to 3 days.  The reporter stated that the patient had chills at evening and arm soreness.
Moderate headache and body aches for 10 hours. Two cold sores the 2-3 weeks afterward.
Swelling at injection site, next day red blotches, muscle soreness, swelling continues, sore underneath arm. On 6/7 tenderness gone. Underneath arm muscle is tender.
Patient was admitted to hospital on 05/13/2021 with bilateral pulmonary emboli  with cor pulmonale. He received the Johnson and Johnson Covid 19 vaccination on 04/09/2021 thirty four days earlier.
sweating; slept for 13 hours and got up every hour to drink; a insatiable thirst; no appetite; arm hurts a little after the vaccination but this time it did and it is still sore; chills all night; a massive headache; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional via physician via Agency (Reference number- 00899708) and transmitted to Sanofi on 15-Dec-2021.  This case involves a 63 year old female patient who experienced sweating (hyperhidrosis), slept for 13 hours and got up every hour to drink (Sleep disorder), insatiable thirst (thirst), no appetite (decreased appetite), arm hurts a little after the vaccination but this time it did and it is still sore (pain in extremity), chills all night (chills) and a massive headache (headache) after receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's medical history, medical treatment(s), past vaccination(s) and family history were not provided. She had no other vaccines   On 14-Dec-2021, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE produced by Sanofi Pasteur (lot number and expiry date was not reported) via intramuscular route in the deltoid not otherwise specified (nos) for prophylactic vaccination.  On 14-Dec-2021, the patient developed a non-serious sweating (hyperhidrosis), slept for 13 hours and got up every hour to drink (Sleep disorder), insatiable thirst (thirst), no appetite (decreased appetite), arm hurts a little after the vaccination but this time it did and it is still sore (pain in extremity), chills all night (chills) and a massive headache (headache) on the same following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  It was reported "Consumer of FLUZONE (unsure of presentation) reporting a potential adverse event after receiving the vaccination consumer states she received the vaccine yesterday 14Dec2021 and experienced a massive headache, no appetite, and a insatiable thirst" in addition she states that she had sweating and chills all night and still is experiencing a headache" the consumer also states that she slept for (13) hours and got up every hour to drink, she states that her arm hurts a little after the vaccination but this time it did and it is still sore, she is unsure about which Flu vaccine that she got as the vaccine was already prepared when she received the dose, she did state that the syringes had a pink needle".  No laboratory data was reported.  It was not reported if the patient received any corrective treatment for the events.  The reporter did not report causality of events with suspect.  At time of reporting, the patient did not recover from the events.  There will be no information available on the batch number for this case.